MedTrace Logo

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

NCT00929201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-08-13

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Sitagliptin phosphate/metformin hydrochloride FDC

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

DRUG

Sitagliptin phosphate

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

DRUG

Metformin hydrochloride

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-03-31
Completion
2008-05-31

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00929201 on ClinicalTrials.gov