A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets | RxWiki

A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets

Overview[ - collapse ][ - ]

Purpose	A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
Condition	Type 2 Diabetes
Intervention	Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: metformin 500 mg 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: metformin 1000 mg
Phase	Phase 1
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00961857
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	December 2005
Estimated Primary Completion Date	January 2006
Current Primary Outcome Measures	The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets [Time Frame: 72 hours post dose] [Designated as safety issue: No]
Current Secondary Outcome Measures	Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets [Time Frame: 72 hours post dose] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets
Official Title	An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets
Brief Summary	A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
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 500 mg A single dose of metformin 500 mg tablets Other Names: ApotexDrug: Comparator: sitagliptin A single 50 mg tablet of sitagliptin Drug: 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: metformin 1000 mg A single dose of metformin 1000 mg tablets Other Names: Apotex
Study Arm (s)	Active Comparator: Treatment A Individual Tablets of 50 mg sitagliptin and 500 mg metformin Experimental: Treatment B Sitagliptin/metformin 50 mg/500 mg tablet Active Comparator: Treatment C Individual Tablets of 50 mg sitagliptin and 1000 mg metformin Experimental: Treatment D sitagliptin/metformin 50 mg/1000 mg tablet

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	48
Estimated Completion Date	January 2006
Estimated Primary Completion Date	December 2005
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 - Subject is willing to avoid strenuous physical activity during the study - Subject agrees to refrain from eating grapefruit or grapefruit products during the study 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 consumes excessive amounts of alcohol or caffeinated beverages - Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks - Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food - Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin - Subject is a regular user or past abuser of any illicit drugs - Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study. - Subject is a nursing mother
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00961857
Other Study ID Numbers	2009_635
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