A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 28
- Primary Endpoint
- Cmax for Sitagliptin and Metformin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Co-administration of 50 mg sitagliptin and 500 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/500 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 850 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/850 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 500 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/500 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 850 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/850 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 500 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/500 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 850 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/850 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 500 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/500 mg tablet (Drug)
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
Intervention: Co-administration of 50 mg sitagliptin and 850 mg metformin (Drug)
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
Intervention: sitagliptin/metformin 50 mg/850 mg tablet (Drug)
Outcomes
Primary Outcomes
Cmax for Sitagliptin and Metformin
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported