Phase 1
N=12
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00944450 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) — 8.38; 8.78 μmol*hr/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Sitagliptin phosphate anhydrous formulation (Drug); Comparator: sitagliptin phosphate monohydrate form (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) |
8.38; 8.78 | — |
| PRIMARY Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) |
799; 856 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is in good health
- Female subjects must have a negative pregnancy test
- Subject is within 30% of ideal body weight
- Subject does not smoke
- Subject agrees to follow the study guidelines
Exclusion Criteria
- Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
- Subject has a history of hypoglycemia
- Subject has a history of any hepatic disease
- Subject is taking any oral, parenteral, topical or implantable contraceptives
Data sourced from ClinicalTrials.gov (NCT00944450). 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.