drugset / Trial / NCT00910663
Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
RandomizedCrossoverOpen-labelOther
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.
Timeline
- Start
- 2006-10
- Primary completion
- 2006-11
- Completion
- 2006-11
Outcome
Met primary endpoint
registry Geometric Test/Ref Ratio x 100 97.01 (90% CI 90.01 to 104.55) NCT00910663 ↗
registry Geometric Test/Ref Ratio x 100 102.81 (90% CI 100.23 to 105.45) NCT00910663 ↗
registry Geometric Test/Ref Ratio x 100 103.35 (90% CI 100.51 to 106.27) NCT00910663 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 250 mg | Oral |
Indications
No indication recorded.