NCT01080443

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition

Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single Dose Two-way Crossover Oral Bioequivalence Study of Mycophenolate Mofetil Capsules 250 mg in Normal Healthy Adult Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Panacea Biotec Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fasting conditions, and to assess the bioequivalence.

Detailed description

48 +8 (stand-by) normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose administration and for at least 4 hours post dose. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 28 blood samples will be withdrawn for pharmacokinetic profiling. The concentration of mycophenolate mofetil and mycophenolic acid will be quantitated using validated LC-MS / MS method.ANOVA, two one-sided tests for bioequivalence, power and ratio analysis for un-transformed and ln-transformed pharmacokinetic parameters Cmax, AUC0-t AUC0-inf will be computed and reported for Mycophenolic acid. Bioequivalence of the test product with that of the reference product under fasting conditions will be concluded if the 90% confidence interval falls within the acceptance range of 80.00-125.00% for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Mycophenolic acid.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil Capsule 250 mg	Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2010-03-04
• Last updated: 2010-03-12

Locations

1 site across 1 country: India