A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)

A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of the FMI Sitagliptin/Metformin 50/500 mg, 50/850 mg and 50/1000 mg FDC Tablet and Co-administration of Corresponding Doses of Sitagliptin and Metformin as Individual Tablets

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961480

Enrollment

Registered

2009-08-19

Start date

2007-10-31

Completion date

2007-11-30

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).

Interventions

DRUGsitagliptin phosphate (+) metformin hydrochloride

place holder - do not post

DRUGComparator: metformin 500mg

A single dose of metformin 500 mg tablet

DRUGComparator: sitagliptin

A single dose of 50 mg sitagliptin tablet

DRUGComparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

DRUGComparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

DRUGComparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

DRUGComparator: metformin 1000 mg

A single dose of metformin 1000 mg tablet

DRUGComparator: metformin 850 mg

A single dose of metformin 850 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

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 is a nursing mother * Subject consumes excessive amounts of alcohol or caffeine * Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks

Design outcomes

Primary

Measure	Time frame
The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.	Up to 72 hours postdose

Secondary

Measure	Time frame
Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.	Up to 72 hours postdose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026