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A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00961480
Collaborator
(none)
24
Enrollment
6
Arms
1
Duration (Months)

Study Details

Study Description

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-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).

Condition or Disease Intervention/Treatment Phase
  • Drug: sitagliptin phosphate (+) metformin hydrochloride
  • Drug: Comparator: metformin 500mg
  • Drug: Comparator: sitagliptin
  • Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet
  • Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
  • Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
  • Drug: Comparator: metformin 1000 mg
  • Drug: Comparator: metformin 850 mg
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of the FMI Sitagliptin/Metformin 50/500 mg, 50/850 mg and 50/1000 mg FDC Tablet and Co-administration of Corresponding Doses of Sitagliptin and Metformin as Individual Tablets
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment A

50 mg sitagliptin and 500 mg metformin as individual tablets

Drug: sitagliptin phosphate (+) metformin hydrochloride
place holder - do not post

Drug: Comparator: metformin 500mg
A single dose of metformin 500 mg tablet
Other Names:
  • Glucophage

    • Drug: Comparator: sitagliptin
    A single dose of 50 mg sitagliptin tablet
    Other Names:
  • Januvia

    		•
    Experimental: Treatment B

    sitagliptin/metformin 50 mg/500 mg tablet

    Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet
    A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
    Active Comparator: Treatment C

    50 mg sitagliptin and 1000 mg metformin as individual tablets

    Drug: Comparator: sitagliptin
    A single dose of 50 mg sitagliptin tablet
    Other Names:
  • Januvia

    • Drug: Comparator: metformin 1000 mg
    A single dose of metformin 1000 mg tablet
    Other Names:
  • Glucophage

    		•
    Experimental: Treatment D

    sitagliptin/metformin 50 mg/1000 mg tablet

    Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
    A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
    Active Comparator: Treatment E

    50 mg sitagliptin and 850 mg metformin as individual tablets

    Drug: Comparator: sitagliptin
    A single dose of 50 mg sitagliptin tablet
    Other Names:
  • Januvia

    • Drug: Comparator: metformin 850 mg
    A single dose of metformin 850 mg tablet
    Other Names:
  • Glucophage

    		•
    Experimental: Treatment F

    sitagliptin/metformin 50 mg/850 mg tablet

    Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
    A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

    Outcome Measures

    Primary Outcome Measures

    1. The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. [Up to 72 hours postdose]

    Secondary Outcome Measures

    1. Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. [Up to 72 hours postdose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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 Criteria:

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00961480
    Other Study ID Numbers:
    • 0431A-095
    • MK0431A-095
    • 2009_636
    First Posted:
    Aug 19, 2009
    Last Update Posted:
    Jun 9, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Metformin
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Jun 9, 2015