drugset / Trial / NCT00859521

Levetiracetam 1000 mg Under Fasting Conditions

NCT00859521 ↗

Phase 1 Completed 30 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

THe objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fasting conditions.

Timeline

Start
2007-01
Primary completion
2007-01
Completion
2007-01

Outcome

Met primary endpoint

registry analysis (unspecified test); Levetiracetam vs Keppra®; Ratio of Geometric Means 96.7 (90% CI 92.4 to 101) NCT00859521 ↗

registry analysis (unspecified test); Levetiracetam vs Keppra®; Ratio of Geometric Means 98.4 (90% CI 96.9 to 100) NCT00859521 ↗

registry analysis (unspecified test); Levetiracetam vs Keppra®; Ratio of Geometric Means 98.8 (90% CI 97.2 to 100) NCT00859521 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 1000 mg Oral

Indications

No indication recorded.