drugset / Trial / NCT00830258

Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

NCT00830258 ↗

Phase 1 Completed 60 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.

Timeline

Start
2005-04
Primary completion
2005-04
Completion
2005-04

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 105.76 (90% CI 98.17 to 113.93) NCT00830258 ↗

registry Geometric Test/Ref Ratio x 100 110.45 (90% CI 104.31 to 116.96) NCT00830258 ↗

registry Geometric Test/Ref Ratio x 100 110.61 (90% CI 104.39 to 117.20) NCT00830258 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pravastatin Small molecule 80 mg —

Indications

No indication recorded.