NCT01513044

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions

An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult,human, male subjects under fasting conditions.

Detailed description

This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under Fasting conditions. 72 healthy male adults were enrolled. A washout period of 7 days was maintained between the successive dosing days.One capsule containing mycophenolate mofetil 250 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 two hours after dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
DRUG	Mycophenolate Mofetil	250 mg capsules of Roche Laboratories Inc.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2012-01-20
• Last updated: 2012-01-20

Locations

1 site across 1 country: India