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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes

Treatments

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
Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01093794
0431A-122
2010_518

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 4 patient groups

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850
Experimental group
Description:
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
Treatment:
Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
Drug: sitagliptin/metformin 50 mg/850 mg tablet
Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
Drug: sitagliptin/metformin 50 mg/500 mg tablet
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC
Experimental group
Description:
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
Treatment:
Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
Drug: sitagliptin/metformin 50 mg/850 mg tablet
Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
Drug: sitagliptin/metformin 50 mg/500 mg tablet
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500
Experimental group
Description:
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
Treatment:
Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
Drug: sitagliptin/metformin 50 mg/850 mg tablet
Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
Drug: sitagliptin/metformin 50 mg/500 mg tablet
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Experimental group
Description:
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
Treatment:
Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
Drug: sitagliptin/metformin 50 mg/850 mg tablet
Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
Drug: sitagliptin/metformin 50 mg/500 mg tablet

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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