A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
NCT ID: NCT00961480
Last Updated: 2015-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2007-10-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment A
50 mg sitagliptin and 500 mg metformin as individual tablets
sitagliptin phosphate (+) metformin hydrochloride
place holder - do not post
Comparator: metformin 500mg
A single dose of metformin 500 mg tablet
Comparator: sitagliptin
A single dose of 50 mg sitagliptin tablet
Treatment B
sitagliptin/metformin 50 mg/500 mg tablet
Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
Treatment C
50 mg sitagliptin and 1000 mg metformin as individual tablets
Comparator: sitagliptin
A single dose of 50 mg sitagliptin tablet
Comparator: metformin 1000 mg
A single dose of metformin 1000 mg tablet
Treatment D
sitagliptin/metformin 50 mg/1000 mg tablet
Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
Treatment E
50 mg sitagliptin and 850 mg metformin as individual tablets
Comparator: sitagliptin
A single dose of 50 mg sitagliptin tablet
Comparator: metformin 850 mg
A single dose of metformin 850 mg tablet
Treatment F
sitagliptin/metformin 50 mg/850 mg tablet
Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
Interventions
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sitagliptin phosphate (+) metformin hydrochloride
place holder - do not post
Comparator: metformin 500mg
A single dose of metformin 500 mg tablet
Comparator: sitagliptin
A single dose of 50 mg sitagliptin tablet
Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
Comparator: metformin 1000 mg
A single dose of metformin 1000 mg tablet
Comparator: metformin 850 mg
A single dose of metformin 850 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is in good health and is a non-smoker
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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MK0431A-095
Identifier Type: -
Identifier Source: secondary_id
2009_636
Identifier Type: -
Identifier Source: secondary_id
0431A-095
Identifier Type: -
Identifier Source: org_study_id
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