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: July 22, 2015
Last verified: July 2015
  Purpose

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet 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 FDC
Drug: Sitagliptin phosphate
Drug: Metformin hydrochloride
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: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
    Serum samples were used to determine the AUC from time 0 to infinity for metformin.


Secondary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of Metformin [ Time Frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose ] [ Designated as safety issue: No ]
    Serum samples were used to determine the maximum concentration for metformin.


Enrollment: 61
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sita + Met then Sita/Met FDC
Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.
Drug: Sitagliptin phosphate/metformin hydrochloride FDC
Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.
Drug: Sitagliptin phosphate
Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Drug: Metformin hydrochloride
Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Active Comparator: Sita/Met FDC then Sita + Met
Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
Drug: Sitagliptin phosphate/metformin hydrochloride FDC
Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.
Drug: Sitagliptin phosphate
Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Drug: Metformin hydrochloride
Single dose metformin 500 mg tablet 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:

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

Exclusion Criteria:

  • has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
  • is a nursing mother
  • 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 Director 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, MK-0431A-080, 2009_607
Study First Received: June 25, 2009
Results First Received: January 5, 2010
Last Updated: July 22, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2015