drugset / Trial / NCT00907907
Mycophenolate Mofetil Tablets Under Fasting Conditions
RandomizedCrossoverOpen-labelOther
Summary
The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a single-dose in healthy subjects under fasting conditions.
Timeline
- Start
- 2006-07
- Primary completion
- 2006-08
- Completion
- 2006-08
Outcome
Met primary endpoint
registry Geometric Test/Ref Ratio x 100 93.97 (90% CI 80.25 to 110.04) NCT00907907 ↗
registry Geometric Test/Ref Ratio x 100 102.01 (90% CI 98.74 to 105.39) NCT00907907 ↗
registry Geometric Test/Ref Ratio x 100 99.91 (90% CI 95.99 to 103.98) NCT00907907 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 500 mg | — |
Indications
No indication recorded.