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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: 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

• Registration Number: NCT01093794
• Lead Sponsor: Merck Sharp & Dohme LLC

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 available

Study Timeline

• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Study Start: 2010-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-03
• Results First Submitted QC: 2011-06-03
• Results First Posted: 2011-06-27
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	Co-administration of 50 mg sitagliptin and 500 mg metformin	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
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	Co-administration of 50 mg sitagliptin and 850 mg metformin	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
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	Co-administration of 50 mg sitagliptin and 500 mg metformin	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
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	Co-administration of 50 mg sitagliptin and 500 mg metformin	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
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	Co-administration of 50 mg sitagliptin and 850 mg metformin	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
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	Co-administration of 50 mg sitagliptin and 500 mg metformin	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
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	Co-administration of 50 mg sitagliptin and 850 mg metformin	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
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	sitagliptin/metformin 50 mg/500 mg tablet	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
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850	sitagliptin/metformin 50 mg/850 mg tablet	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
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	sitagliptin/metformin 50 mg/500 mg tablet	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
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	sitagliptin/metformin 50 mg/500 mg tablet	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
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	Co-administration of 50 mg sitagliptin and 850 mg metformin	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
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC	sitagliptin/metformin 50 mg/850 mg tablet	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
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500	sitagliptin/metformin 50 mg/850 mg tablet	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
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	sitagliptin/metformin 50 mg/500 mg tablet	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
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC	sitagliptin/metformin 50 mg/850 mg tablet	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

Primary Outcome Measures

Name	Time	Method
Cmax for Sitagliptin and Metformin	baseline through 72 hours postdose	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.
Area Under the Curve (AUC(0-t)) for Sitagliptin	baseline through 72 hours postdose	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.