drugset / Trial / NCT00911274
Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
RandomizedCrossoverOpen-labelOther
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.
Timeline
- Start
- 2006-10
- Primary completion
- 2006-11
- Completion
- 2006-11
Outcome
Met primary endpoint
registry Geometric Test/Ref Ratio x 100 92.41 (90% CI 82.77 to 103.18) NCT00911274 ↗
registry Geometric Test/Ref Ratio x 100 101.30 (90% CI 97.84 to 104.88) NCT00911274 ↗
registry Geometric Test/Ref Ratio x 100 101.00 (90% CI 97.77 to 104.34) NCT00911274 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 250 mg | Oral |
Indications
No indication recorded.