Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin hydrochloride; Drug: Sitagliptin phosphate; Drug: Sitagliptin phosphate/metformin hydrochloride FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929201

2009_607 (Other Identifier)

0431A-080

MK-0431A-080 (Other Identifier)

Details and patient eligibility

About

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Enrollment: 61 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• is in good health
• is a nonsmoker
• is willing to follow all study guidelines

Exclusion criteria

• has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
• is a nursing mother
• is unwilling to consume the required high-fat breakfast

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Sita + Met then Sita/Met FDC

Active Comparator group

Description:

Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.

Treatment:

Drug: Metformin hydrochloride

Drug: Sitagliptin phosphate

Drug: Sitagliptin phosphate/metformin hydrochloride FDC

Sita/Met FDC then Sita + Met

Active Comparator group

Description:

Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.

Treatment:

Drug: Metformin hydrochloride

Drug: Sitagliptin phosphate

Drug: Sitagliptin phosphate/metformin hydrochloride FDC