A Phase I, Single-Center, Open-Label, Non-randomized, One-Sequence Crossover, Pharmacokinetic Interaction Study of the Combination Product VI-0521 (Phentermine Plus Topiramate) With Metformin, Sitagliptin or Probenecid in Healthy Subjects

NCT00842400 Phase 1 COMPLETED

The purposes of this study are to: * Find out how much of the study drugs are in the blood of healthy subjects after taking multiple doses of VI-0521, metformin and sitagliptan. * Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy subjects after taking multiple doses. * Find out how much topiramate is in the semen of healthy male subjects after taking multiple doses.

Details

Lead sponsor	VIVUS LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2009-02
Completion	2009-04

Conditions

• Obesity

Interventions

• Metformin, VI-0521, Sitagliptan, Probenecid

Primary outcomes

• The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin. — 40 days

Countries

United States