NCT00778349

A Comparitive Bioavailability Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fasting Conditions and After Low and High Fat Meal

A Randomized, Three-Treatment, Three-Period, Six-Sequence, Single-Dose, Crossover Pharmacokinetic Study on Metformin Hydrochloride Solution 100 mg/mL of Ranbaxy Laboratories Comparing the Pharmacokinetic Profile of Metformin Under Fasting Condition, After a Low Fat Meal and After a High Fat Meal in Healthy, Adult, Human Male Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000 mg) under fasting conditions, after a Iow fat meal and after a high fat meal

Detailed description

This study was an open label, randomized, three-treatment, three-period, six-sequence, single-dose, crossover pharmacokinetic study planned on 36 healthy, adult, human subjects under fasting conditions. However 34 subjects were enrolled and 33 subjects completed all the periods of the study. All periods were separated by a washout of seven days As per protocol (Appendix 1), enough healthy, adult, human subjects were to be enrolled in the study to allow the dosing of 36 subjects in the first period. 34 subjects were enrolled and 33 subjects completed all the periods of study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metformin solution 100 mg/mL

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-05-01
• Completion: 2002-07-01
• First posted: 2008-10-23
• Last updated: 2008-10-23