Status:
COMPLETED
A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy Subjects.
Lead Sponsor:
VIVUS LLC
Conditions:
Obesity
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief 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 effec...
Detailed Description
This trial is an open-label, non-randomized, one-sequence crossover study. All subjects will receive an oral dose of metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34; an oral do...
Eligibility Criteria
Inclusion
- The study population will consist of adult healthy males or females, 19-45 years of age; inclusive who are medically healthy with no clinically significant screening results.
Exclusion
- Main exclusion criteria include a history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator; any clinically significant laboratory abnormalities as judged by the Investigator; any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure; presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy; any history of a cardiovascular or cerebrovascular event; any active malignancy except basal cell carcinoma; systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 95 mm Hg at screening or at check-in (Two rechecks are allowed); positive drug/alcohol test at screening or check in; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. In female subjects, a positive pregnancy test at screening or check-in is exclusionary.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00842400
Start Date
February 1 2009
End Date
April 1 2009
Last Update
January 21 2010
Active Locations (1)
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1
MDS Pharma Services
Phoenix, Arizona, United States, 85283