A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets
Overview[ - collapse ][ - ]
| Purpose | A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III). |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: metformin 500mg Drug: Comparator: sitagliptin Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet Drug: Comparator: metformin 1000 mg Drug: Comparator: metformin 850 mg |
| Phase | Phase 1 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00961480 |
| First Received | August 18, 2009 |
| Last Updated | April 7, 2010 |
| Last verified | April 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 18, 2009 |
|---|---|
| Last Updated Date | April 7, 2010 |
| Start Date | October 2007 |
| Estimated Primary Completion Date | December 2007 |
| Current Primary Outcome Measures | The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. [Time Frame: Up to 72 hours postdose] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. [Time Frame: Up to 72 hours postdose] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets |
|---|---|
| Official Title | A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of the FMI Sitagliptin/Metformin 50/500 mg, 50/850 mg and 50/1000 mg FDC Tablet and Co-administration of Corresponding Doses of Sitagliptin and Metformin as Individual Tablets |
| Brief Summary | A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: sitagliptin phosphate (+) metformin hydrochloride place holder - do not post Drug: Comparator: metformin 500mg A single dose of metformin 500 mg tablet Other Names: GlucophageDrug: Comparator: sitagliptin A single dose of 50 mg sitagliptin tablet Other Names: JanuviaDrug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet Drug: Comparator: metformin 1000 mg A single dose of metformin 1000 mg tablet Other Names: GlucophageDrug: Comparator: metformin 850 mg A single dose of metformin 850 mg tablet Other Names: Glucophage |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 24 |
| Estimated Completion Date | December 2007 |
| Estimated Primary Completion Date | November 2007 |
| Eligibility Criteria | Inclusion Criteria: - Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception - Subject is in good health and is a non-smoker Exclusion Criteria: - Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder - Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases - Subject is a nursing mother - Subject consumes excessive amounts of alcohol or caffeine - Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00961480 |
|---|---|
| Other Study ID Numbers | 2009_636 |
| Has Data Monitoring Committee | No |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | April 2010 |