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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin phosphate anhydrous formulation

• Registration Number: NCT00944450
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2004-09
• Study Completion: 2004-11
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-23
• Results First Submitted: 2010-02-24
• Results First Submitted QC: 2010-04-06
• Results First Posted: 2010-04-27
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Sitagliptin phosphate anhydrous formulation	Sitagliptin anhydrous formulation

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Through 72 Hours Following the Administration of the Medication	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)	Through 72 Hours Following the Administration of the Medication	Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)