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

NCT00518466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-06-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Wesley W Day, PhD · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-09-30
Completion
2007-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00518466 on ClinicalTrials.gov