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Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01093794
First received: March 19, 2010
Last updated: August 5, 2014
Last verified: August 2014

March 19, 2010
August 5, 2014
April 2010
June 2010   (final data collection date for primary outcome measure)
  • Area Under the Curve (AUC(0-t)) for Sitagliptin [ Time Frame: baseline through 72 hours postdose ] [ Designated as safety issue: No ]
    AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
  • Cmax for Sitagliptin and Metformin [ Time Frame: baseline through 72 hours postdose ] [ Designated as safety issue: No ]
    Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
  • Area Under the Curve (AUC(0-t)) for sitagliptin and metformin [ Time Frame: baseline through 72 hours postdose ] [ Designated as safety issue: No ]
  • Cmax for sitagliptin [ Time Frame: baseline through 72 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC(0-t)) for metformin [ Time Frame: baseline through 72 hours postdose ] [ Designated as safety issue: No ]
  • Cmax for metformin [ Time Frame: baseline through 72 hours postdose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01093794 on ClinicalTrials.gov Archive Site
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Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
    Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.
  • Drug: sitagliptin/metformin 50 mg/500 mg tablet
    Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
  • Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
    Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.
  • Drug: sitagliptin/metformin 50 mg/850 mg tablet
    Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
  • Experimental: 1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850

    Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

    • Co-administration of 50 mg sitagliptin and 500 mg metformin
    • sitagliptin/metformin 50 mg/500 mg FDC tablet
    • sitagliptin/metformin 50 mg/850 mg FDC tablet
    • Co-administration of 50 mg sitagliptin and 850 mg metformin
    Interventions:
    • Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
    • Drug: sitagliptin/metformin 50 mg/500 mg tablet
    • Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
    • Drug: sitagliptin/metformin 50 mg/850 mg tablet
  • Experimental: 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC

    Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

    • sitagliptin/metformin 50 mg/500 mg FDC tablet
    • Co-administration of 50 mg sitagliptin and 850 mg metformin
    • Co-administration of 50 mg sitagliptin and 500mg metformin
    • sitagliptin/metformin 50 mg/850 mg FDC tablet
    Interventions:
    • Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
    • Drug: sitagliptin/metformin 50 mg/500 mg tablet
    • Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
    • Drug: sitagliptin/metformin 50 mg/850 mg tablet
  • Experimental: 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500

    Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

    • Co-administration of 50 mg sitagliptin and 850 mg metformin
    • sitagliptin/metformin 50 mg/850 mg FDC tablet
    • sitagliptin/metformin 50 mg/500 mg FDC tablet
    • Co-administration of 50 mg sitagliptin and 500mg metformin
    Interventions:
    • Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
    • Drug: sitagliptin/metformin 50 mg/500 mg tablet
    • Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
    • Drug: sitagliptin/metformin 50 mg/850 mg tablet
  • Experimental: 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

    Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

    • sitagliptin/metformin 50 mg/850 mg FDC tablet
    • Co-administration of 50 mg sitagliptin and 500 mg metformin
    • Co-administration of 50 mg sitagliptin and 850 mg metformin
    • sitagliptin/metformin 50 mg/500 mg FDC tablet
    Interventions:
    • Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
    • Drug: sitagliptin/metformin 50 mg/500 mg tablet
    • Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
    • Drug: sitagliptin/metformin 50 mg/850 mg tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is of Chinese descent
  • Subject is in good health
  • Subject is a non-smoker

Exclusion Criteria:

  • Subject has a history of stroke or chronic seizures
  • Subject has a history of cancer
  • Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01093794
0431A-122, 2010_518
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP