Trials / Completed
CompletedNCT00910663
Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Mycophenolate Mofetil Capsules Under Fed Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (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 availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available reference product, CellCept® 250 mg capsule administered to healthy subjects under fed conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Conditions
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
- 2010-05-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00910663. Inclusion in this directory is not an endorsement.