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

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ClinicalTrials.gov Identifier: NCT01093794
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : June 27, 2011
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes 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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet
Study Start Date : April 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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: 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
 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: 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
 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: 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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve (AUC(0-t)) for Sitagliptin [ Time Frame: baseline through 72 hours postdose ]
    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.

  2. Cmax for Sitagliptin and Metformin [ Time Frame: baseline through 72 hours postdose ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093794


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01093794    
Other Study ID Numbers: 0431A-122
2010_518
First Posted: March 26, 2010    Key Record Dates
Results First Posted: June 27, 2011
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action