Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122) | RxWiki

Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes
Intervention	Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin Drug: sitagliptin/metformin 50 mg/500 mg tablet Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin Drug: sitagliptin/metformin 50 mg/850 mg tablet
Phase	Phase 1
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT01093794
First Received	March 19, 2010
Last Updated	June 3, 2011
Last verified	June 2011

Tracking Information[ + expand ][ + ]

First Received Date	March 19, 2010
Last Updated Date	June 3, 2011
Start Date	April 2010
Estimated Primary Completion Date	June 2010
Current Primary Outcome Measures	Area Under the Curve (AUC(0-t)) for Sitagliptin [Time Frame: baseline through 72 hours postdose] [Designated as safety issue: No]AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg. Cmax for Sitagliptin and Metformin [Time Frame: baseline through 72 hours postdose] [Designated as safety issue: No]Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Official Title	A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet
Brief 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.
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: Co-administration of 50 mg sitagliptin and 500 mg metformin Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours. Drug: sitagliptin/metformin 50 mg/500 mg tablet Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours. Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours. Drug: sitagliptin/metformin 50 mg/850 mg tablet Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
Study Arm (s)	Experimental: 1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850 Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: Co-administration of 50 mg sitagliptin and 500 mg metformin sitagliptin/metformin 50 mg/500 mg FDC tablet sitagliptin/metformin 50 mg/850 mg FDC tablet Co-administration of 50 mg sitagliptin and 850 mg metformin Experimental: 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: sitagliptin/metformin 50 mg/500 mg FDC tablet Co-administration of 50 mg sitagliptin and 850 mg metformin Co-administration of 50 mg sitagliptin and 500mg metformin sitagliptin/metformin 50 mg/850 mg FDC tablet Experimental: 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500 Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: Co-administration of 50 mg sitagliptin and 850 mg metformin sitagliptin/metformin 50 mg/850 mg FDC tablet sitagliptin/metformin 50 mg/500 mg FDC tablet Co-administration of 50 mg sitagliptin and 500mg metformin Experimental: 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: sitagliptin/metformin 50 mg/850 mg FDC tablet Co-administration of 50 mg sitagliptin and 500 mg metformin Co-administration of 50 mg sitagliptin and 850 mg metformin sitagliptin/metformin 50 mg/500 mg FDC tablet

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	28
Estimated Completion Date	June 2010
Estimated Primary Completion Date	June 2010
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
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01093794
Other Study ID Numbers	MK-0431A-122
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	June 2011