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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: sitagliptin phosphate monohydrate form; Drug: Sitagliptin phosphate anhydrous formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944450

MK0431-027

2009_614

0431-027

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

1

Active Comparator group

Description:

Sitagliptin anhydrous formulation

Treatment:

Drug: Sitagliptin phosphate anhydrous formulation

2

Active Comparator group

Description:

Sitagliptin monohydrate FMI formulation

Treatment:

Drug: Comparator: sitagliptin phosphate monohydrate form