NCT01283841

Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions

An Open-label, Balanced, Randomized, Two-treatment, Four-period, Two Sequence, Single Dose, Replicate, Crossover, Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablet of Dr. Reddy's Laboratories Limited Comparing With That of Cellcept 500 mg Tablet of Roche Laboratories in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under fasting conditions and to assess the bioequivalence.

Detailed description

This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first three hours after dosing.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	Mycophenolate Mofetil 500 mg tablets

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2011-01-26
• Last updated: 2011-01-26

Locations

1 site across 1 country: India