Phase 1
Completed N=28
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Source: ClinicalTrials.gov NCT01093794 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Area Under the Curve (AUC(0-t)) for Sitagliptin — 1570; 1590; 1520; 1600 hr*ng/mL
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.
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 | — |
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
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. Informational only — not medical advice.