drugset
drugset / Trial / NCT00834717

Granisetron 1 mg Tablets Under Fasting Conditions

NCT00834717 ↗

Phase 1 Completed 40 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 fasting conditions.

Timeline

Start
2005-09
Primary completion
2005-09
Completion
2005-09

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 97.86 (90% CI 92.36 to 103.69) NCT00834717 ↗

registry Geometric Test/Ref Ratio x 100 92.57 (90% CI 82.80 to 103.48) NCT00834717 ↗

registry Geometric Test/Ref Ratio x 100 92.95 (90% CI 83.11 to 103.97) NCT00834717 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Granisetron Other / unclassified 2 mg —

Indications

No indication recorded.