Phase 1
Completed N=61
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
Source: ClinicalTrials.gov NCT00929201 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin — 7.65; 7.45 μg * hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin |
7.65; 7.45 | — |
| SECONDARY Peak Plasma Concentration (Cmax) of Metformin |
929; 887 | — |
Eligibility Criteria
Inclusion Criteria
- is in good health
- is a nonsmoker
- is willing to follow all study guidelines
Exclusion Criteria
- has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
- is a nursing mother
- is unwilling to consume the required high-fat breakfast
Data sourced from ClinicalTrials.gov (NCT00929201). 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.