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

NCT ID: NCT00944450

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2004-11-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Sitagliptin anhydrous formulation

Group Type: ACTIVE_COMPARATOR

Sitagliptin phosphate anhydrous formulation

Intervention Type: DRUG

Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.

2

Sitagliptin monohydrate FMI formulation

Group Type: ACTIVE_COMPARATOR

Comparator: sitagliptin phosphate monohydrate form

Intervention Type: DRUG

Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.

Interventions

Sitagliptin phosphate anhydrous formulation

Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.

Intervention Type: DRUG

Comparator: sitagliptin phosphate monohydrate form

Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0431-027

Identifier Type: -

Identifier Source: secondary_id

2009_614

Identifier Type: -

Identifier Source: secondary_id

0431-027

Identifier Type: -

Identifier Source: org_study_id