Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions

Summary

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

Timeline

Start

2002-06

Primary completion

2002-07

Completion

2002-07

Outcome

Met primary endpoint

registry Ratio of the LS Mean (Test/Ref x 100) 98.39 (90% CI 94.36 to 102.59) NCT00905346 ↗

registry Ratio of the LS Mean (Test/Ref x 100) 102.92 (90% CI 99.88 to 106.05) NCT00905346 ↗

registry Ratio of the LS Mean (Test/Ref x 100) 102.63 (90% CI 99.24 to 106.14) NCT00905346 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	50 mg	—

Indications

No indication recorded.