Status:
COMPLETED
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-adminis...
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
- Subject is willing to avoid strenuous physical activity during the study
- Subject agrees to refrain from eating grapefruit or grapefruit products during the study
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 consumes excessive amounts of alcohol or caffeinated beverages
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
- Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
- Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
- Subject is a regular user or past abuser of any illicit drugs
- Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
- Subject is a nursing mother
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00961857
Start Date
December 1 2005
End Date
January 1 2006
Last Update
November 13 2019
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