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

NCT00944450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-08-19

Study results available
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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

Interventions

DRUG

Sitagliptin phosphate anhydrous formulation

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

DRUG

Comparator: sitagliptin phosphate monohydrate form

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

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
2004-08-31
Primary Completion
2004-09-30
Completion
2004-11-30

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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 NCT00944450 on ClinicalTrials.gov