drugset / Trial / NCT00849797

Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

NCT00849797 ↗

Phase 1 Completed 120 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.

Timeline

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

Outcome

Met primary endpoint

registry Test/Ref Ratio of LS Means x 100 90.86 (90% CI 85.47 to 96.60) NCT00849797 ↗

registry Test/Ref Ratio of LS Means x 100 98.60 (90% CI 96.59 to 100.66) NCT00849797 ↗

registry Test/Ref Ratio of LS Means x 100 98.74 (90% CI 96.71 to 100.80) NCT00849797 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxcarbazepine Small molecule 600 mg —

Indications

No indication recorded.