drugset
drugset / Trial / NCT00834522

Granisetron 1 mg Tablets, Non-fasting

NCT00834522 ↗

Phase 1 Completed 80 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fed conditions.

Timeline

Start
2005-07
Primary completion
2005-07
Completion
2005-07

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 103.79 (90% CI 99.40 to 108.37) NCT00834522 ↗

registry Geometric Test/Ref Ratio x 100 104.37 (90% CI 97.04 to 112.25) NCT00834522 ↗

registry Geometric Test/Ref Ratio x 100 104.22 (90% CI 96.90 to 112.08) NCT00834522 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Granisetron Other / unclassified 2 mg —

Indications

No indication recorded.