Effect of silymarin pretreatment on the bioavailability of domperidone in healthy human volunteers

2014 ◽  
Vol 29 (4) ◽  
Author(s):  
Shravan Kumar Yamsani ◽  
Madhusudan Rao Yamsani
Keyword(s):  
Oral Bioavailability ◽  
Pharmacokinetic Parameters ◽  
Rat Intestine ◽  
Healthy Human ◽  
P Glycoprotein ◽  
Human Volunteers ◽  
Significant Difference

AbstractThe aim of this study was to investigate the effect of silymarin pretreatment on domperidone oral bioavailability in humans.The rats were pretreated with silymarin for 7 days. The transport of domperidone across the rat intestine (duodenum, jejunum, ileum, and colon) was studied by usingIn the everted sac and non-everted sac study with silymarin pretreatment, domperidone transport increased from the duodenum, jejunum, ileum, and colon. The silymarin pretreatment increased the bioavailability of domperidone. There was a statistically significant difference in the pharmacokinetic parameters CThe significant difference in absorption of domperidone on pretreatment with silymarin is due to the inhibition of P-glycoprotein and CYP3A. Silymarin, which inhibits CYP3A4, should be contraindicated for domperidone.

Pharmacokinetic Evaluation of Two Brands of Linezolid Tablets in Healthy Human Volunteers

2010 ◽  
Vol 3 (2) ◽  
pp. 933-939
Author(s):  
Parameshwar P ◽  
Y N Rao ◽  
Shobha J C ◽  
Y N Reddy ◽  
V M Reddy
Keyword(s):  
Lower Limit ◽  
Bioequivalence Study ◽  
Hplc Method ◽  
Pharmacokinetic Parameters ◽  
Healthy Human ◽  
Blood Samples ◽  
Upper Limit ◽  
Human Volunteers ◽  
Significant Difference ◽  
Healthy Adult Male

The aim of a  randomized, balanced, two treatment, two-period, two-sequence, single-dose, crossover pilot bioavailability and bioequivalence study conducted in 12 healthy adult male volunteers under fasting conditions was to compare steady state pharmacokinetics of Linezolid 600mg tablets of Dr.Reddy’s Laboratories Ltd, and Zyvox ® (Linezolid) 600mg tablets of Pharmacia & Upjohn Company, USA. The subjects were dosed once during the study and the pre-dose blood samples were collected within 1 hr prior to dosing. The concentrations of Linezolid from the blood samples were quantified by validated HPLC method and pharmacokinetic parameters were computed. 90% Confidence intervals of reference Vs test for Cmax  lower limit 87.23 and upper limit 109.24, AUC0-t lower limit 86.20 and upper limit 109.17, AUCO-α lower limit 85.48 and upper limit 111.54. Analysis of variance (ANOVA) did not show significant difference to these parameters. Based on the results obtained, both the formulations have exhibited the same rate and extent of absorption, indicating switch ability in clinical practice.

scholarly journals A Liquid Chromatography-Tandem Mass Spectrometry Method for Evaluation of Two Brands of Enalapril 20 mg Tablets in Healthy Human Volunteers

2017 ◽  
Vol 2017 ◽  
pp. 1-8
Author(s):  
Wael Abu Dayyih ◽  
Mohammed Hamad ◽  
Ahmad Abu Awwad ◽  
Eyad Mallah ◽  
Zainab Zakarya ◽  
...  
Keyword(s):  
Enzyme Inhibitor ◽  
Internal Standard ◽  
Pharmacokinetic Parameters ◽  
Healthy Human ◽  
Chronic Heart Disease ◽  
Chromatography Tandem Mass Spectrometry ◽  
Human Volunteers ◽  
Treatment Of Hypertension ◽  
Liquid Chromatography Tandem Mass ◽  
Enalapril And Enalaprilat

Enalapril is an angiotensin-converting enzyme inhibitor used for treatment of hypertension and chronic heart disease. Enalaprilat is its active metabolite responsible for the activity. This study aimed to develop and validate a method for enalapril and enalaprilat analysis and to determine the bioequivalence of two tablet formulae of enalapril. LC-MS/MS bioanalytical method was developed and validated and then applied to evaluate the bioavailability of two enalapril formulae. Antihyperglycemic sitagliptin was used as internal standard (IS). The method was accurate for the within- and between-days analysis, and precise CV% was <5%, being linear over the calibration range 1.0–200.0 ng/ml. Stability was >85% and the LOD was 0.907 and 0.910 ng/ml for enalapril and enalaprilat, respectively, and LLOQ was 1 ng/ml. The pharmacokinetic parameters Cmax, tmax, AUC0–72, and AUC0–∞ values of enalapril and enalaprilat of the two formulae were calculated and nonsignificant differences were found. A linearity, specific, accurate, and precise method was developed and applied for the analysis of enalapril and enalaprilat in human plasma after oral administration of two formulae of enalapril 20 mg tablets in healthy volunteers. Depending on the statistical analysis it was concluded that the two enalapril formulae were bioequivalent.

scholarly journals Allium sativumL. Improves Visual Memory and Attention in Healthy Human Volunteers

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Sara Tasnim ◽  
Parsa Sanjana Haque ◽  
Md. Sazzadul Bari ◽  
Md. Monir Hossain ◽  
Sardar Mohd. Ashraful Islam ◽  
...  
Keyword(s):  
Executive Function ◽  
Verbal Memory ◽  
Visual Memory ◽  
Neuropsychological Test ◽  
Healthy Human ◽  
Beneficial Effects ◽  
Memory And Attention ◽  
Human Volunteers ◽  
Short Period ◽  
Significant Difference

Studies have shown thatAllium sativumL. (AS) protects amyloid-beta peptide-induced apoptosis, prevents oxidative insults to neurons and synapses, and thus prevent Alzheimer’s disease progression in experimental animals. However, there is no experimental evidence in human regarding its putative role in memory and cognition. We have studied the effect of AS consumption by healthy human volunteers on visual memory, verbal memory, attention, and executive function in comparison to control subjects taking placebo. The study was conducted over five weeks and twenty volunteers of both genders were recruited and divided randomly into two groups: A (AS) and B (placebo). Both groups participated in the 6 computerized neuropsychological tests of the Cambridge Neuropsychological Test Automated Battery (CANTAB) twice: at the beginning and after five weeks of the study. We found statistically significant difference (p<0.05) in several parameters of visual memory and attention due to AS ingestion. We also found statistically nonsignificant (p>0.05) beneficial effects on verbal memory and executive function within a short period of time among the volunteers. Study for a longer period of time with patients suffering from neurodegenerative diseases might yield more relevant results regarding the potential therapeutic role of AS.

scholarly journals Vomiting is a Potential Adverse Drug Reaction for Levomilnacipran

2017 ◽  
Vol 9 (05) ◽  
Author(s):  
Atreyee Sarkar ◽  
Shivanand Dhanure
Keyword(s):  
Adverse Drug Reaction ◽  
Adverse Reaction ◽  
Extended Release ◽  
Pharmacokinetic Parameters ◽  
Regulatory Requirements ◽  
Healthy Human ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Human Volunteers ◽  
The Us

Levomilnacipran is a drug used to treat depression. Micro Labs is a generic drug company which had developed an extended release formulation of Levomilnacipran 120 mg capsule. Two studies were conducted to assess the safety, tolerability and bioequivalence of the extended release formulation of 120 mg Levomilnacipran capsules. A total of 42 subjects had been included for each of the fasting and fed studies. Out of them, 30 subjects completed the fasting study and 28 subjects completed the fed study. Pharmacokinetic parameters like Cmax, AUC0-t, AUC0-inf, Tmax, Kel, t1/2 and %AUCextra were calculated for Levomilnacipran in order to compare the bioavailability of the test and reference formulations. The studies were conducted in healthy human volunteers in both fasting and fed conditions as per the US regulatory requirements for conduct of bioequivalence studies. The formulations were found to be bioequivalent to each other. Vomiting was observed as a major adverse reaction.

Effect of rifampicin pretreatment on the oral bioavailability of domperidone in healthy human volunteers

2015 ◽  
Vol 30 (4) ◽  
Author(s):  
Adukondalu Devandla ◽  
Shravan Kumar Yamsani ◽  
Madhusudan Rao Yamsani
Keyword(s):  
Compartmental Model ◽  
Pharmacokinetic Parameters ◽  
Serum Concentrations ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Healthy Human ◽  
Once Daily ◽  
Treatment Conditions ◽  
Human Volunteers ◽  
Daily Dose

AbstractIncreased exsorption of domperidone was observed from different parts of the small intestine of the rat after pretreatment with rifampicin by the everted sac method. Based on theAfter an overnight fast, 20 mg domperidone was administered to the volunteers, either alone or after 6 days pretreatment with a once daily dose of 600 mg rifampicin. Serum concentrations of domperidone were estimated by reverse phase HPLC. Pharmacokinetic parameters were determined based on non-compartmental model analysis using the computer program kinetica.Rifampicin pretreatment decreased Cmax, AUCoThis interaction may have clinical significance when domperidone is co-administered with rifampicin in chronic treatment conditions, such as tuberculosis, leprosy and other infections of joints, bones, etc.

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