Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00944450
First received: July 21, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Sitagliptin phosphate anhydrous formulation
Drug: Comparator: sitagliptin phosphate monohydrate form
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, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of Tablet Formulations Containing the Anhydrous and Monohydrate (FMI) Forms of MK0431

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) [ Time Frame: Through 72 Hours Following the Administration of the Medication ] [ Designated as safety issue: No ]
    Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

  • Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) [ Time Frame: Through 72 Hours Following the Administration of the Medication ] [ Designated as safety issue: No ]
    Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)


Enrollment: 12
Study Start Date: August 2004
Study Completion Date: November 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sitagliptin anhydrous formulation
Drug: Sitagliptin phosphate anhydrous formulation
Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
Active Comparator: 2
Sitagliptin monohydrate FMI formulation
Drug: Comparator: sitagliptin phosphate monohydrate form
Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good health
  • Female subjects must have a negative pregnancy test
  • Subject is within 30% of ideal body weight
  • Subject does not smoke
  • Subject agrees to follow the study guidelines

Exclusion Criteria:

  • Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
  • Subject has a history of hypoglycemia
  • Subject has a history of any hepatic disease
  • Subject is taking any oral, parenteral, topical or implantable contraceptives
  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: NCT00944450

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

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00944450     History of Changes
Other Study ID Numbers: 0431-027, MK0431-027, 2009_614
Study First Received: July 21, 2009
Results First Received: February 24, 2010
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
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 28, 2014