drugset / Trial / NCT00905606

Topiramate 25 mg Tablets Under Fasting Conditions

NCT00905606 ↗

Phase 1 Completed 30 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fasting conditions.

Timeline

Start
2001-06
Primary completion
2001-06
Completion
2001-06

Outcome

Met primary endpoint

registry Ratio of the LS Mean (test/ref x 100) 93.91 (90% CI 85.42 to 103.25) NCT00905606 ↗

registry Ratio of the LS Mean (test/ref x 100) 98.27 (90% CI 94.63 to 102.05) NCT00905606 ↗

registry Ratio of the LS Mean (test/ref x 100) 98.19 (90% CI 94.64 to 101.87) NCT00905606 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Topiramate Small molecule 50 mg —

Indications

No indication recorded.