Phase 1 N=28 Randomized Treatment

Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01093794 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Area Under the Curve (AUC(0-t)) for Sitagliptin — 1570; 1590; 1520; 1600 hr*ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Co-administration of 50 mg sitagliptin and 500 mg metformin (Drug); sitagliptin/metformin 50 mg/500 mg tablet (Drug); Co-administration of 50 mg sitagliptin and 850 mg metformin (Drug); sitagliptin/metformin 50 mg/850 mg tablet (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve (AUC(0-t)) for Sitagliptin	1570; 1590; 1520; 1600; 8350; 8750	—
PRIMARY Cmax for Sitagliptin and Metformin	189; 182; 187; 194; 1210; 1310	—

Summary

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

Eligibility Criteria

Inclusion Criteria

Subject is of Chinese descent
Subject is in good health
Subject is a non-smoker

Exclusion Criteria

Subject has a history of stroke or chronic seizures
Subject has a history of cancer
Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01093794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.