drugset / Trial / NCT00649467

Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

NCT00649467

Phase 1 Completed 35 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.

Timeline

Start
2005-11
Primary completion
2005-12
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Topiramate Small molecule 25 mg Oral

Indications

No indication recorded.