drugset / Trial / NCT00518466

Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults

NCT00518466

Phase 1 Completed 64 enrolled VIVUS LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.

Timeline

Start
2007-07
Primary completion
2007-09
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentermine Small molecule 7.5 mg
Subject Phentermine Small molecule 37.5 mg
Subject Topiramate Small molecule 25 mg
Subject Topiramate Small molecule 100 mg

Indications