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A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)

NCT00961480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-06-09

No results posted yet for this study

Summary

A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).

Conditions

Interventions

DRUG

sitagliptin phosphate (+) metformin hydrochloride

place holder - do not post

DRUG

Comparator: metformin 500mg

A single dose of metformin 500 mg tablet

DRUG

Comparator: sitagliptin

A single dose of 50 mg sitagliptin tablet

DRUG

Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

DRUG

Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

DRUG

Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

DRUG

Comparator: metformin 1000 mg

A single dose of metformin 1000 mg tablet

DRUG

Comparator: metformin 850 mg

A single dose of metformin 850 mg tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-11-30
Completion
2007-11-30

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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 NCT00961480 on ClinicalTrials.gov