Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00929201
First received: June 25, 2009
Last updated: May 9, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00929201     History of Changes
Other Study ID Numbers: 0431A-080, MK0431A-080, 2009_607
Study First Received: June 25, 2009
Results First Received: January 5, 2010
Last Updated: May 9, 2014
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014