NCT00518466

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

A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	topiramate	25 mg modified-release capsules
DRUG	phentermine	7.5 mg immediate-release capsules
DRUG	topiramate	100 and 25 mg immediate-release tablets
DRUG	phentermine	37.5 and 7.5 mg immediate-release tablets

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-09-01
• Completion: 2007-12-01
• First posted: 2007-08-20
• Last updated: 2011-06-08

Locations

1 site across 1 country: United States