drugset / Trial / NCT00908128

Mycophenolate Mofetil Tablets Under Fed Conditions

NCT00908128 ↗

Phase 1 Completed 40 enrolled Teva Pharmaceuticals USA
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 fed conditions.

Timeline

Start
2006-08
Primary completion
2006-08
Completion
2006-08

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 90.96 (90% CI 82.40 to 100.41) NCT00908128 ↗

registry Geometric Test/Ref Ratio x 100 99.16 (90% CI 96.24 to 102.16) NCT00908128 ↗

registry Geometric Test/Ref Ratio x 100 98.78 (90% CI 95.76 to 101.89) NCT00908128 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 500 mg —

Indications

No indication recorded.