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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Sitagliptin phosphate anhydrous formulation; Drug: Comparator: sitagliptin phosphate monohydrate form

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Through 72 Hours Following the Administration of the Medication
Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Through 72 Hours Following the Administration of the Medication

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-027; MK0431-027; 2009_614