Pharmacokinetic Study of Two Oral Formulations of Levofloxacin in Healthy Male Volunteersl

The objective of this study was to compare different pharmacokinetic parameters of a local (X) and reference (Tavanic) formulations of levofloxacin 250 mg tablets after oral administration of a single dose under fasting condition. Thirteen blood samples were collected from each of the eight Bangladeshi healthy male volunteers over 24 hours after oral administration of the drugs. Serum levofloxacin concentrations were determined by HPLC assay using UV detection, and pharmacokinetic parameters were determined by the non-compartmental method. Mean ± SD of Cmax, AUC0-24, AUC0-α, Tmax, t1/2, kel, were 4.33 ± 1.16 and 4.56 ± 1.51 ?g/mL, 45.90 ± 8.74 and 37.77 ± 9.94 hr-?g /mL, 79.94 ± 32.80 and 66.85 ± 35.43 hr-?g/mL, 1.22 ± 0.49 and 1.28 ± 0.41, 19.90 ± 11.49 and 21.00 ± 16.39 hr, 0.04 ± 0.02 and 0.05 ± 0.03 hr -1 for the local (X) and reference formulation, respectively. From the paired t-test, the p-values for two formulations were found to be 0.182, 0.412 and 0.725 for AUC0-24, AUC0-α, and Cmax respectively. The 90% confidence intervals of the mean of the difference between log-transformed values for Cmax were almost within the bioequivalence accepted range of 80% to 125%, namely: (78.90%, 118.36%); but for AUC0-24 and AUC0-α the values were are beyond the acceptable range. (100.83%, 146.52%) and (94.34%, 157.89%) respectively. The results indicate that the two formulations are not bioequivalent for both the rate and extent of absorption. Key words: Levofloxacin, pharmacokinetic, bioavailability, bioequivalence Dhaka Univ. J. Pharm. Sci. Vol.5(1-2) 2006 The full text is of this article is available at the Dhaka Univ. J. Pharm. Sci. website

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Intravenous Busulfan: Pharmacokinetic Disposition and Clinical Outcomes in Children Undergoing Hematopoietic Stem Cell Transplant.

Blood ◽

10.1182/blood.v106.11.1760.1760 ◽

2005 ◽

Vol 106 (11) ◽

pp. 1760-1760

Author(s):

Tal Schechter ◽

Yaron Finkelstein ◽

John Doyle ◽

Zulfikaral Verjee ◽

Gideon Koren ◽

...

Keyword(s):

Stem Cell ◽

Oral Administration ◽

Hematopoietic Stem Cell ◽

Conditioning Regimen ◽

Significant Proportion ◽

Pharmacokinetic Parameters ◽

Cell Transplant ◽

Older Children ◽

Hematopoietic Stem ◽

The Mean

Abstract Background: Conditioning regimens preceding hematopoietic stem cell transplantation (HSCT) for various malignant and non-malignant diseases in children often include busulfan. Busulfan administration may be complicated by hepatic veno-occlusive disease (HVOD). A relationship has been described between high systemic exposure to busulfan after oral administration, as measured by area under the curve (Bu-AUC) and HVOD. Recently, IV busulfan (IV Bu) administration has been reported to be associated with a much lower incidence of HVOD than oral administration in adults. Objectives: To describe the pharmacokinetics of IVBu in infants (<1 year of age) and children. To determine the incidence of HVOD in children undergoing conditioning with IV Bu, and to correlate IV Bu AUC with the development of HVOD and neutrophil engraftment. Methods: Twenty-four children who underwent HSCT at The Hospital for Sick Children between April 2003 and September 2004 and received IV Bu as part of their conditioning regimen were included in this retrospective study. Diagnoses included: AML (6), metabolic storage disease (6), immune deficiency syndromes (4), histiocytosis (2), beta-thalassemia (2), WAS (1), MDS (1), CML (1), relapsed meduloblastoma (1). Initial IV Bu doses were based on actual patient weight: <9kg =0.95mg/kg/dose; 9–16kg =1.2mg/kg/dose; 16–23kg =1.1mg/kg/dose; 24–34kg =0.95mg/kg/dose; >34kg =0.8mg/kg/dose. Seven blood samples were drawn after the first IV Bu dose for determination of plasma busulfan concentrations. Pharmacokinetic parameters were calculated using 1-compartment analysis (WinNonLin 4.1). The third and subsequent IV Bu doses were adjusted to achieve an AUC of 900–1500μMol•min. HVOD (modified Baltimore criteria) and engraftment (ANC > 0.5 x 109/L) were evaluated. Results: The median patient age was 3.5 years (range 3mo–16.9yrs), including 9 infants. Mean IV Bu pharmacokinetic parameters were: Cmax=4.7±0.9μMol; Vss=0.70±0.22L/kg; ke=0.005±0.001min−1; AUC=1256±320μMol•min. The mean IV Bu AUC of infants was not different from older children (1164μ±331Mol•min vs. 1311±311μMol•min; p=0.35). The mean Vss was higher in infants than older children (0.84±0.29L/kg vs. 0.62±0.10L/kg; p=0.025), but the mean clearance was not different when corrected for body weight. Twenty-three patients (95.8%) engrafted between day +10 to +27. HVOD was diagnosed in 6 patients (25%), including 3 infants. Five patients had moderate HVOD and one had fatal HVOD. Mean IV Bu AUC was 1317±310μMol•min and 1074±299μMol•min in the non- HVOD vs. the HVOD group, respectively (p=0.10). The number of children who did not engraft precluded assessment of the relationship between IV Bu AUC and engraftment. Conclusions: Busulfan Vss differs significantly between infants and older children. A significant proportion of patients developed HVOD. No association was observed between IV Bu AUC and the development of HVOD in children where busulfan doses are adjusted to achieve a target IV Bu AUC.

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Impact of PCB Manufacturing Process Variations on Trace Impedance

International Symposium on Microelectronics ◽

10.4071/isom-2011-tha1-paper3 ◽

2011 ◽

Vol 2011 (1) ◽

pp. 000891-000895 ◽

Cited By ~ 3

Author(s):

Abdelghani Renbi ◽

Johan Carlson ◽

Jerker Delsing

Keyword(s):

Phase Shift ◽

Manufacturing Process ◽

Characteristic Impedance ◽

Process Variations ◽

P Values ◽

Pcb Manufacturing ◽

The Mean ◽

The Difference ◽

The Impact ◽

Measured Phase

This paper demonstrates statistically the impact of PCB manufacturing variations on the characteristic impedance. Moreover, it shows that the characteristics of the PCBs vary across different suppliers. These differences cannot be tolerated in some applications where the characteristic impedance is restricted to be within a specific range. We sampled 3 × 20 PCBs, each batch of twenty is ordered from a different manufacturer. The sampling consist of measuring the phase shift between the reected and the incident signals when injecting a 180 MHz sinewave into a PCB trace. The trace is selected to be the same for all samples. All the PCBs are ordered to be identical and designed for 50 Ω devices. Our conclusion was drawn after running the T-tests to assess statistically the significance of the difference occurring between the PCBs. Based on the computed P-values all the three batches are different from each other in the mean of the measured phase shift with 95 % confidence. The difference between the measured and the expected characteristic impedance is found as 3 %, 10 % and 20 % for these three manufacturers. We also witnessed board-to-board variations even within the same batch and from the same supplier due to the process instability by looking at the probability density of having the same phase shift that is equal to the mean. Some samples shown 2.6 % to 3.5 % difference above the mean.

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Induction of theophylline clearance by rifampin and rifabutin in healthy male volunteers.

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.40.8.1866 ◽

1996 ◽

Vol 40 (8) ◽

pp. 1866-1869 ◽

Cited By ~ 15

Author(s):

J G Gillum ◽

J M Sesler ◽

V L Bruzzese ◽

D S Israel ◽

R E Polk

Keyword(s):

Treatment Phase ◽

Pharmacokinetic Parameters ◽

Theophylline Clearance ◽

Healthy Male ◽

Time Curve ◽

Concentration Time ◽

Male Volunteers ◽

Hepatic Microsomal Enzyme ◽

The Mean ◽

To Receive

Rifampin and rifabutin induce the metabolism of many drugs, which may result in subtherapeutic concentrations and failure of therapy. However, differences between rifabutin and rifampin in potency of induction, and the specific enzymes which are altered, are not clear. This study, involving 12 adult male volunteers, compared the effects of 14-day courses of rifampin and rifabutin on clearance of theophylline, a substrate for the hepatic microsomal enzyme CYP1A2. Subjects were given oral theophylline solution (5 mg/kg of body weight) on day 1 and then randomized to receive daily rifampin (300 mg) or rifabutin (300 mg) on days 3 to 16. Theophylline was readministered as described above on day 15. The first treatment sequence was followed by a 2-week washout period; subjects then received the alternative treatment. Theophylline concentrations were determined for 46 h after each dose, and pharmacokinetic parameters were determined. One subject developed flu-like symptoms while taking rifabutin and withdrew voluntarily. Results from the remaining 11 subjects are reported. Compared with the baseline, the mean area under the concentration-time curve (AUC) (+/- standard deviation) for theophylline declined significantly following rifampin treatment (from 140 +/- 37 to 100 +/- 24 micrograms . h/ml, P <0.001); there was no significant change following rifabutin treatment (136 +/- 48 to 128 +/- 45 micrograms.h/ml). Baseline theophylline AUCs before each treatment phase were not different. A comparison of equal doses of rifampin and rifabutin administered to healthy volunteers for 2 weeks indicates that induction of CYP1A2, as measured by theophylline clearance, is significantly less following rifabutin treatment than it is following rifampin treatment. However, the relative induction potency for other metabolic enzymes remains to be investigated.

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Bioavalaibility and pharmacokinetic comparison of two formulations of metformin 850 mg tablets in healthy Colombian volunteers

Colombia Medica ◽

10.25100/cm.v42i1.754 ◽

2011 ◽

pp. 81-87 ◽

Cited By ~ 1

Author(s):

Gloria Holguín ◽

Fanny Cuesta ◽

Rosendo Archbold ◽

Margarita Restrepo ◽

Sergio Parra ◽

...

Keyword(s):

Hplc Method ◽

Pharmacokinetic Parameters ◽

Logarithmic Mean ◽

Reference Formulation ◽

Anova Analysis ◽

Double Blind ◽

Metformin Concentration ◽

The Mean ◽

Carry Over ◽

Logarithmic Ratio

Purpose: The aim of this study was to compare the bioavailability of two formulations of metformin 850 mg tablets: Glucophage® from Merck Santè laboratories (reference product) and Metformin from Winthrop Pharmaceuticals de Colombia SA (test product) in healthy Colombian volunteers. Methods: A random, double blind, two-period, two-week wash out period, crossover study was performed in 24 healthy male and female volunteers for a single 850-mg dose of metformin tablets administrated with 240 ml of water after 12 hours of fasting. Once the drug was administrated, blood samples were collected before and within 24 hour, and plasma metformin concentration was determined by using a validated HPLC method. Pharmacokinetic parameters such as Cmax, AUC0-96h, AUC0-∞, and Tmax were determined. The formulations were considered bioequivalent if the logarithmic mean ratios of ln-transformed Cmax and AUC0-∞ values were within the equivalence range of 80%-125%. Results: ANOVA analysis of the ln-transformed Cmax and AUC0-∞ indicated that none of the effects examined (formulation, period, within and between-subjet variances and carry over) was statistically significant. The mean (±SD) of Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-∞, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 2.57 (± 0.93) h vs. 2.22 (± 0.94) h were obtained with test and reference formulations, respectively. These pharmacokinetic parameters presented differences with the results from other published papers. The 90% confidence interval of the logarithmic ratio of AUC0-∞ and Cmax was within the range of 80-125%. Conclusions: In this study in healthy Colombian volunteers, a single 850-mg dose of metformin tablet test formulation met the criteria for bioequivalence to the reference formulation based on pharmacokinetic parameters AUC0-∞ and Cmax.

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Pharmacokinetic Parameters of Ciprofloxacin in Bangladeshi Volunteers: A Preliminary Evaluation

Bangladesh Journal of Physiology and Pharmacology ◽

10.3329/bjpp.v27i1-2.20066 ◽

2014 ◽

Vol 27 (1-2) ◽

pp. 1-8

Author(s):

Reefat Zaman Chowdhury ◽

Md Saiful Islam ◽

Md Sayedur Rahman

Keyword(s):

Healthy Volunteers ◽

Oral Route ◽

Absolute Bioavailability ◽

Pharmacokinetic Parameters ◽

Intravenous Route ◽

Population Pharmacokinetic ◽

Healthy Male ◽

Healthy Male Volunteers ◽

Male Volunteers ◽

The Difference

The present study has attempted to establish a High-performance liquid chromatography (HPLC) method to determine ciprofloxacin in plasma, in order to evaluate the bioavailability of ciprofloxacin. In this study, initially 8 (eight) Bangladeshi Bangalee healthy male volunteers and 7 (seven) Bangladeshi Tribal healthy male volunteers received 500 mg tablet of pioneer brand of ciprofloxacin in oral route. Blood samples were collected at 0, 30, 60, 120, 180, 360, 540 and 720 minutes after drug administration. After 1 week of washout period, same volunteers of two groups received 200 mg injection of pioneer brand of ciprofloxacin in intravenous route. HPLC with ultraviolet detection was used to quantify plasma ciprofloxacin concentrations. In case of oral route, AUC012h, Cmax, Tmax and T1/2 values for Bangladeshi Bangalee and Tribal healthy volunteers were 545.53 ± 32.35 & 655.74 ± 16.57 ?g min/mL, 2.19 ± 0.16 & 2.49 ± 0.20 ?g/mL, 75.00 ± 27.77 & 94.29 ± 32.07 min and 241.96 ± 13.53 & 242.02 ± 19.88 min respectively. In case of intravenous route, the AUC012h, Cmax, Tmax and T1/2 values for Bangladeshi Bangalee and Tribal healthy volunteers were 344.07 ± 29.31 & 343.31 ± 25.34 ?g min/mL, 2.47 ± 0.17 & 2.46 ± 0.18 ?g/mL, 30.00 ± 0.00 & 30.0 ± 0.0 min and 278.16 ± 1.74 & 272.74 ± 4.42 min respectively and the difference between these two groups of volunteers was not significant. The difference in AUC012h, Cmax, Tmax and T1/2 values between these two groups of volunteers was significant. The mean percent absolute bioavailability in Bangladeshi Bangalee and Tribal healthy volunteers was 64.04 ± 3.21 and 76.81 ± 6.71 respectively. In conclusion, pharmacokinetic parameters of ciprofloxacin significantly varied among Bangladeshi Bangalee and Bangladeshi Tribal healthy volunteers indicating necessity of further study on population pharmacokinetic in these groups of people. DOI: http://dx.doi.org/10.3329/bjpp.v27i1-2.20066 Bangladesh J Physiol Pharmacol 2011;27(1&2):1-8.

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Studies of the pharmacokinetics of morroniside and loganin in rat after oral administration of raw and wine-processed Corni fructus by UPLC-QqQ-MS/MS

Tropical Journal of Pharmaceutical Research ◽

10.4314/tjpr.v20i2.27 ◽

2022 ◽

Vol 20 (2) ◽

pp. 411-418

Author(s):

Wei Wang ◽

Xuechun Wang ◽

Qiang Zhang ◽

Ru Jia ◽

Chunjie Du ◽

...

Keyword(s):

Oral Administration ◽

Multiple Reaction Monitoring ◽

Internal Standard ◽

Negative Ion ◽

Pharmacokinetic Parameters ◽

Tissue Samples ◽

Multiple Reaction Monitoring Mode ◽

The Mean ◽

Corni Fructus ◽

Negative Ion Mode

Purpose: To study the pharmacokinetics of morroniside (MR) and loganin (LG) in rats after oral administration of raw and wine-processed Corni fructus by UPLC-QqQ-MS/MS. Methods: Arctiin (AT) was used as internal standard, and the plasma or tissue samples were extracted twice using ethyl acetate. Electrospray ionization (ESI) negative ion mode was used, and the multiple reaction monitoring mode (MRM) was set in acquisition mode. The extraction and detection method is supported by selectivity, sensitivity, precision, accuracy, stability, extraction, recovery and matrix effect. The non-atrioventricular model of das2.0 software was used to calculate the pharmacokinetic parameters. Results: The absorption rate of MR (PTmax=0.092) and LG (PTmax=0.092) in Corni Fructus after wine-processing was faster in rats. The mean residence time was longer, and distribution of MR (PMRT0~t = 0.294) and LG (PMRT0~t = 0.000) in wine-processed Corni Fructus group increased in liver and kidneys. Conclusion: The proposed method has been successfully validated and is suitable for studying the pharmacokinetics of the two analytes in rats.

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Comparative Pharmacokinetic Study of Taxifolin after Oral Administration of Fructus Polygoni Orientalis Extract in Normal and Fibrotic Rats by UPLC-MS/MS

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/9348075 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Feili Wei ◽

Li Guo ◽

Yongsong Xu ◽

Dexi Chen ◽

Muxin Gong

Keyword(s):

Liver Fibrosis ◽

Oral Administration ◽

Residence Time ◽

Mean Residence Time ◽

Internal Standard ◽

Rat Plasma ◽

Pharmacokinetic Parameters ◽

Porcine Serum ◽

Validation Parameters ◽

The Mean

Fructus polygoni orientalis (FPO) is widely used in clinical practice in China, especially in treatment of liver diseases including viral hepatitis, liver fibrosis, and liver cirrhosis. However, its pharmacokinetic (PK) alterations in liver fibrotic rats have rarely been reported. To study whether taxifolin, one of the main flavonoids in FPO can be absorbed into blood after oral administration of FPO extract and to compare the differences in pharmacokinetic parameters of taxifolin to normal and liver fibrotic rats induced by porcine serum (PS), a UPLC-MS/MS method was developed and validated for determination of taxifolin in rat plasma using puerarin as the internal standard (IS). All validation parameters met the acceptance criteria according to regulatory guidelines. The results indicated that after treatment of rats with PS alone for 12 weeks, the liver fibrotic model group was built successfully. The taxifolin can be absorbed into the blood after oral administration of the FPO extract. The Cmax of taxifolin was 1940 ± 502.2 ng/mL and 2648 ± 208.5 ng/mL (p<0.05), the AUC0∼t of taxifolin was 4949.7 ± 764.89 h·ng/mL and 6679.9 ± 734.26 h·ng/mL (p<0.05), the AUC0∼∞ of taxifolin was 5049.4 ± 760.7 and 7095.2 ± 962.3 h·ng/mL (p<0.05), and the mean residence time (MRT) of taxifolin was 2.46 ± 0.412 h and 3.17 ± 0.039 h (p<0.05) in the normal and fibrotic model groups, respectively. These results confirmed that the pharmacokinetic parameters of taxifolin are altered in liver fibrosis, manifested as Cmax, AUC0∼t, AUC0∼∞, and the mean residence time (MRT). It suggested that it is essential to consider the characteristics of pharmacokinetics after oral administration of FPO in liver disease patients.

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Preparation and Comparative Bioavailability Studies of Indomethacin-Loaded Cetyl Alcohol Microspheres

Journal of Pharmaceutics ◽

10.1155/2013/109837 ◽

2013 ◽

Vol 2013 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

N. Vishal Gupta ◽

D. V. Gowda ◽

V. Balamuralidhara ◽

M. S. Khan

Keyword(s):

Size Range ◽

Spherical Shape ◽

Cetyl Alcohol ◽

Pharmacokinetic Parameters ◽

Healthy Male ◽

Sem Images ◽

Comparative Bioavailability ◽

Extent Of Absorption

The purpose of the present study was to compare the in vitro release and to find out whether the bioavailability of a 75 mg indomethacin capsule (Microcid SR) was equivalent to optimized formulation (indomethacin-loaded cetyl alcohol microspheres). Indomethacin-loaded cetyl alcohol microspheres were prepared by meltable emulsified cooling-induced technique. Surface morphology of microspheres has been evaluated using scanning electron microscopy. A single dose, randomized, complete cross over study of IM microspheres was carried out on 10 healthy male and female Albino sheep’s under fasting conditions. The plasma was separated and the concentrations of the drug were determined by HPLC-UV method. Plasma indomethacin concentrations and other pharmacokinetic parameters obtained were statistically analyzed. The SEM images revealed the spherical shape of fat microspheres, and more than 98.0% of the isolated microspheres were in the size range 12–32 μm. DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible. Both formulations were found to be bioequivalent as evidenced by in vivo studies. Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

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Bioequivalence of indinavir capsules in healthy volunteers

Asian Biomedicine ◽

10.2478/abm-2010-0011 ◽

2010 ◽

Vol 4 (1) ◽

pp. 95-101 ◽

Cited By ~ 1

Author(s):

Suvatna Chulavatnatol ◽

Kumthorn Malathum ◽

Sasisopin Kiertiburanakul ◽

Kittisak Sripha ◽

Pojawon Lawanprasert

Keyword(s):

High Performance Liquid Chromatography ◽

High Performance ◽

Plasma Concentrations ◽

Current Treatment ◽

Pharmacokinetic Parameters ◽

Original Formulation ◽

Treatment Objective ◽

The Mean ◽

Success Of Treatment ◽

Extent Of Absorption

Background: Indinavir, one component in the HAART regimen, plays an important role in the current treatment of HIV-infection and AIDS. Availability and accessibility of qualified generic indinavir to patients may be the keys for the success of treatment. Objective: Compare the rate and extent of absorption of a generic indinavir formulation with those of an original formulation in healthy Thai volunteers. Method: A randomized, two-period, two-treatment, two-sequence, crossover study with a two-week washout period was performed. A single dose of 2×400 mg indinavir capsules of each formulation was administered to 24 volunteers after an overnight fast. Indinavir plasma concentrations up to 10 hours postdose were determined using high-performance liquid chromatography. Relevant pharmacokinetic parameters were derived and tested for statistically significant differences using ANOVA and criteria of bioequivalence determination were applied. Results: No statistically significant differences were demonstrated for pharmacokinetic parameters including Cmax, Tmax, AUC0-t, and AUC0-∞ derived from the two formulations (n=23, p>0.05). The criteria of bioequivalence determination i.e., the 90% confidence intervals on the mean ratio (generic/original formulation) of natural logarithmtransformed values of Cmax, AUC0-t and AUC0-∞ were 86.3-106.5%, 94.0-108.5%, and 93.9-108.5%, respectively. Conclusion: As the mean ratios of Cmax, AUC0-t and AUC0-∞ of the generic and original formulations were entirely within the guideline range of bioequivalence (80.0-125.0%), the two formulations were considered bioequivalent in terms of rate and extent of absorption.

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Bioequivalence Study of Donepezil Hydrochloride Tablets in Healthy Male Volunteers

ISRN Pharmacology ◽

10.5402/2012/527679 ◽

2012 ◽

Vol 2012 ◽

pp. 1-4

Author(s):

Noppamas Rojanasthien ◽

Siriluk Aunmuang ◽

Nutthiya Hanprasertpong ◽

Sukit Roongapinun ◽

Supanimit Teekachunhatean

Keyword(s):

High Performance ◽

Reference Product ◽

Bioequivalence Study ◽

Pharmacokinetic Parameters ◽

Two Phase ◽

Test Product ◽

Male Volunteers ◽

Bioequivalence Range ◽

The Mean ◽

The Difference

The objective of this study was to investigate the bioequivalence of two formulations of 5 mg donepezil HCL tablets: Tonizep as the test and Aricept as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 3-week washout period in 20 healthy Thai Male volunteers. After drug administration, serial blood samples were collected over a period of 216 hours. Plasma donepezil concentrations were measured by high performance liquid chromatography with UV detection. Pharmacokinetic parameters were analyzed based on noncompartmental analysis. The logarithmically transformed data of AUC0–∞ and were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio of AUC0–∞ and values of the test product over those of the reference product were 1.08 (1.02–1.14) and 1.08 (0.99–1.17), respectively (within the bioequivalence range of 0.8–1.25). The median for the test product was similar to that of the reference product (2.0 hr), and the 90% CI for the difference between the two preparations was –0.19 to 0.29 hr and within the bioequivalence range of ± 20% of the of the reference formulation. Our study demonstrated the bioequivalence of the two preparations.

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