Sitagliptin/Metformin Fed Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00929201
First received: June 25, 2009
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: sitagliptin phosphate (+) metformin hydrochloride
Drug: Comparator: sitagliptin
Drug: Comparator: metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin [ Time Frame: 72 Hours Post Dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of Metformin [ Time Frame: 72 Hours Post Dose ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Sitagliptin 50 mg and metformin 500 mg individual tablets
Drug: Comparator: sitagliptin
Single dose sitagliptin 50 mg after consumption of a high-fat meal in one of two treatment periods.
Drug: Comparator: metformin
Single dose metformin 500 mg after consumption of a high-fat meal in one of two treatment periods.
Active Comparator: B
Sitagliptin/Metformin 50 mg/500 mg combination tablet
Drug: sitagliptin phosphate (+) metformin hydrochloride
Single dose sitagliptin/metformin 50/500 mg after consumption of a high-fat meal in one of two treatment periods.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good health
  • Subject is a nonsmoker
  • Subject is willing to follow all study guidelines

Exclusion Criteria:

  • Subject has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the subject
  • Subject is a nursing mother
  • Subject is unwilling to consume the required high-fat breakfast
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929201

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00929201     History of Changes
Other Study ID Numbers: 2009_607, MK0431A-080
Study First Received: June 25, 2009
Results First Received: January 5, 2010
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014