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A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy Subjects.

NCT00842400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-01-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Metformin, VI-0521, Sitagliptan, Probenecid

This trial is an open-label, non-randomized, one-sequence crossover study. * metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34 * sitagliptan 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39 * VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39) * 2 g (four 500 mg) probenecid tablets on Day 29.

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Shiyin Yee · VIVUS LLC

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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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 NCT00842400 on ClinicalTrials.gov