Status:
COMPLETED
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-...
Eligibility Criteria
Inclusion
- Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
- Subject is in good health and is a non-smoker
Exclusion
- Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
- Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Subject is a nursing mother
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00961480
Start Date
October 1 2007
End Date
November 1 2007
Last Update
June 9 2015
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