NCT00911274

Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg administered to healthy subjects following an overnight fast of at least 10 hours.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	250 mg Capsule
DRUG	CellCept®	250 mg Capsule

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2009-06-01
• Last updated: 2024-08-19
• Results posted: 2009-09-23

Locations

1 site across 1 country: United States