scholarly journals An open-label, randomized, cross-over bioequivalence study of lafutidine 10 mg under fasting condition

2010 ◽  
Vol 1 (5) ◽  
pp. 112 ◽  
Author(s):  
Bhupesh Dewan
Keyword(s):  
Bioequivalence Study ◽  
Open Label ◽  
Fasting Condition

Bioavailability and pharmacokinetic study of Metformin 500 mg tablet (SR formulations) in healthy human volunteers

2017 ◽  
Vol 3 (3) ◽  
pp. 354-358
Author(s):  
Ashish Kumar ◽  
Pradeep Singh ◽  
Garima Mishra
Keyword(s):  
Bioequivalence Study ◽  
Metformin Hydrochloride ◽  
Reference Standard ◽  
Reference Formulation ◽  
Open Label ◽  
Healthy Human ◽  
Fasting Condition ◽  
Test Formulation ◽  
Acceptable Range ◽  
Human Volunteers

Bioavailability and Bioequivalence studies have become an important part of the clinical research in India. This study was performed to find out the safety and efficacy of two Metformin 500 mg tablet (SR formulations). This study was an open label, balanced, randomized, two treatment, two periods, two sequences, single dose, cross over bioequivalence study under fasting condition. Metformin Hydrochloride (SR) 500 mg tablet was the Test formulation and Dibeta SR tablet [containing Metformin Hydrochloride (SR) 500 mg] was the Reference standard. Volunteers were randomly given a single oral dose of the test and the reference formulation under fasting condition, with a washout period of 07 days. Drug concentration in the plasma samples were quantified by using a validated method on LC/MS/MS. Win Nonlin Version 5.2 software was used for statistical calculations. Cmax, AUC0-t and AUC0-∞ values of the test formulation and reference standard were 89.13%, 87.46%, 88.29%, and 112.44%, 123.85% and 123.87%, respectively. Cmax, AUC0-t and AUC0- ∞ values of the test formulation and reference standard fall within the acceptable range of 80–125%. So, the present study concludes that the test formulation is bioequivalent to the reference standard.

scholarly journals BIOEQUIVALENCE STUDY OF AZELNIDIPINE 16 MG TABLET TO EVALUATE PHARMACOKINETIC PROFILE OF SINGLE DOSE IN HEALTHY, ADULT, HUMAN VOLUNTEERS UNDER FASTING CONDITION

2021 ◽  
pp. 154-159
Author(s):  
DIBYA DAS ◽  
DHIMAN HALDER ◽  
ANIRBANDEEP BOSE ◽  
CHIRANJIT SAHA ◽  
HIMANGSHU SEKHAR MAJI ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Plasma Sample ◽  
Reference Product ◽  
Bioequivalence Study ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Entire Study ◽  
Test Product ◽  
Fasting Condition

Objective: The present study's objective is to conduct a comparative bioavailability study with a special emphasis on the test product's bioequivalence using a standard reference product as a comparator. Methods: Before initiating the bioequivalent study, the plasma sample analysis method was developed and validated by using LC-MS/MS method. The entire study was conducted as a single-dose crossover randomized bioequivalence study with open-label, two treatment, two-period, and two sequences on 24 healthy volunteers under fasting condition. With proper informed consent process the oral dose of the Reference product (R) or Test product (T) was administered on healthy volunteers at 0 h during each period of the study. After the drug's oral administration, a certain quantity of blood sample was collected, and the plasma sample was separated using a cold centrifuge. The plasma samples were analysed by using the validated LC-MS/MS method. The pharmacokinetic parameters, statistical data and ANOVA of the test and reference product were evaluated. Results: The Cmax, Auc0-t, AUC0-∞ and tmax of the test product were found to be 6.29 ng/ml, 117.0 ng. h/ml, 161.67 ng. h/ml and 3.33 h. respectively. And the Cmax, Auc0-t, AUC0-∞ and tmax of reference product were found 6.59 ng/ml, 123.21 ng. h./ml, 172.20 ng. h/ml and 3.38 h respectively. Relative bioavailability was found 94.96%. The overall results show that the 90% confidence intervals (Log-Transformed and Untransformed) for Cmax, AUC0-t and AUC0-∞ for Azelnidipine were within the acceptable limit of 80%-125%. Conclusion: The entire study's conclusion can be drawn as the test product was bioequivalent with the reference product's comparator.

scholarly journals Pharmacokinetics Evaluation of Acamprosate Tablets in Healthy Human Volunteers

2021 ◽  
pp. 79-88
Author(s):  
Kiran S. Chaudhari ◽  
Milind Bagul ◽  
Ketan Shah
Keyword(s):  
Human Subjects ◽  
Bioequivalence Study ◽  
Healthy Male Subject ◽  
Pharmacokinetic Property ◽  
Pharmacokinetic Data ◽  
Open Label ◽  
Healthy Human ◽  
Entire Study ◽  
Fasting Condition ◽  
Single Dosing

Pharmacokinetic data of acamprosate tablets was not accessible on large number of human. Rationale to examine the pharmacokinetic properties of acamprosate calcium in healthy male subject, on single or multiple dosage administration, to evaluate the bioequivalence of two formulations of acamprosate calcium tablets in fast or fed environment. This work engross the study of pharmacokinetic property of Acamprosate calcium tablets in single dosing under fasting condition. Methods: Bioequivalence study of delayed release acamprosate tablets 333 mg for a randomized, single dose, open label, two treatment, two periods, two sequences and crossover design in 12 healthy, adult human subjects under fasting condition was conducted. The wash out period within the each treatment and each stage was 1 week. The quantification of acamprosate was done by LCMS/MS method. Accessibility was evaluated by monitoring adverse events, physical examinations and ECG and laboratory tests. Results: The entire study was conducted by using 12 male subjects to fulfill all stages in the study. The pharmacokinetic calculations for test and reference formulations are as follows: single dosing, Tmax 8.54 ± 5.24 and 10.71 ± 5.41 h, Cmax 146.06 ± 99.73 and 115.01 ±86.26 ng · mL−1, AUC0-t 1391.95 ± 731.24 and 1557.03 ± 960.98 ng·mL−1·h, AUC0–∞ 1987.40 ± 962.84 and 2720.21 ± 1931.79 ng·mL−1·h, respectively. In all three stages, 90% CIs for the test/reference ratio of AUC0–t and AUC0–∞ was to be found within 80% –125% of acamprosate calcium. Conclusions: As per regulatory guidelines, pharmacokinetics parameters for acamprosate calcium were found to be within the acceptance criteria.

Has the Time Come to Employ Population and Individual Bioequivalence for the Evaluation of Generics?

2020 ◽  
Vol 21 (2) ◽  
pp. 112-125
Author(s):  
Francis Micheal ◽  
Mohanlal Sayana ◽  
Rajendra Prasad ◽  
Balamurali Musuvathi Motilal
Keyword(s):  
Therapeutic Index ◽  
Bioequivalence Study ◽  
Open Label ◽  
Statistical Parameters ◽  
Population Mean ◽  
Average Bioequivalence ◽  
Individual Bioequivalence ◽  
Population Bioequivalence ◽  
Enteric Coated ◽  
Bioequivalence Assessment

Background: Bioequivalence studies are a vital part of drug development. The average bioequivalence approach is the standard method of assessment to conclude whether the generic product is bioequivalent to the innovator product. Of late, debates are on whether the average bioequivalence approach adequately addresses drug interchangeability as it considers only population mean for the evaluation especially when highly variable drug products and narrow therapeutic index drugs are dealt with. Hence, the alternative approaches like population bioequivalence and individual bioequivalence assessment approaches emerge as they consider inter/intra-subject variance and subject- by-formulation variance along with population mean. Objectives: The objective of the study was to apply different bioequivalence assessment approaches in a replicate bioequivalence study to evaluate the drug interchangeability. Methods: This was an open-label, single-dose, randomized, balanced, two-treatment, three-period, three-sequence, partial replicate crossover bioequivalence study of omeprazole enteric-coated tablet 20 mg conducted on 48 normal healthy subjects under fed conditions. The plasma concentration of omeprazole was analyzed by a validated bioanalytical method to determine the pharmacokinetic and statistical parameters to assess average bioequivalence, population bioequivalence, and individual bioequivalence. Results: In this study, test formulation was shown to be bio-inequivalent to the reference formulation by average bioequivalence, population bioequivalence, and individual bioequivalence approaches. Conclusion: The outcome of the evaluation clearly states that the bioequivalence outcome of all these approaches are the same. Obviously, it does not mean that these three approaches provide the same outcome though the consideration of variances varies. Certainly, population bioequivalence and individual bioequivalence approach will be more accurate for the assessment of drug interchangeability.

Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers

2021 ◽  
Vol 10 (3) ◽  
pp. 113-118
Author(s):  
Nishalini Harikrishnan ◽  
Ka-Liong Tan ◽  
Kar Ming Yee ◽  
Alia Shaari Ahmad Shukri ◽  
Nalla Ramana Reddy ◽  
...  
Keyword(s):  
Compartmental Analysis ◽  
Bioequivalence Study ◽  
Active Pharmaceutical Ingredient ◽  
Pharmacokinetic Profile ◽  
Time Profile ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Reference Drug ◽  
Test Formulation ◽  
R Ratio

Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 mg tablet formulation. A dissolution study was conducted to optimize the formulation process before evaluating physical changes in the active pharmaceutical ingredient and the formulated product. Methods: This was a randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, two-way crossover, truncated bioequivalence study involving a washout period of ten days. A total of 26 healthy male volunteers were recruited. The pharmacokinetic profile of the test formulation was compared with the reference formulation. Results/Discussion: The pharmacokinetic parameters of ETO were calculated based on the plasma drug concentration-time profile using non-compartmental analysis to determine its safety profile and tolerability. The Test/Reference (T/R) ratio of ETO was 104.36% (90% confidence interval (CI): 98.30%–110.80%) for area under curve (AUC)0-72 while the T/R ratio of maximum concentration (Cmax) was 101.39% (92.15%–111.56%). The 90% CI of the Cmax and AUC0-72 of ETO were within acceptable bioequivalence limits of 80%–125%. All values were within the predetermined limits of the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines. Conclusion: The test formulation was found to be bioequivalent with respect to the reference drug, according to ASEAN bioequivalence guidelines.

scholarly journals Levocetirizine Oral Disintegrating Tablet: A Randomized Open‐Label Crossover Bioequivalence Study in Healthy Japanese Volunteers

2020 ◽  
Vol 9 (7) ◽  
pp. 805-812
Author(s):  
Hiroko Ino ◽  
Masanari Shiramoto ◽  
Takashi Eto ◽  
Miwa Haranaka ◽  
Shin Irie ◽  
...  
Keyword(s):  
Bioequivalence Study ◽  
Open Label ◽  
Oral Disintegrating Tablet
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