drugset / Trial / NCT00849862

Levetiracetam 750 mg Tablets Under Fasting Conditions

NCT00849862 ↗

Phase 1 Completed 22 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-label

Summary

The objective of this study is to compare the rate and extent of absorption of a test formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet under fasting conditions.

Timeline

Start
2005-10
Primary completion
2005-11
Completion
2005-11

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 92.2 (90% CI 85.0 to 100) NCT00849862 ↗

registry Geometric Test/Ref Ratio x 100 100 (90% CI 96.3 to 104) NCT00849862 ↗

registry Geometric Test/Ref Ratio x 100 99.6 (90% CI 96.2 to 103) NCT00849862 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 750 mg —

Indications

No indication recorded.