A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)

An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961857

Enrollment

Registered

2009-08-19

Start date

2005-12-01

Completion date

2006-01-01

Last updated

2019-11-13

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

Interventions

DRUGComparator: metformin 500 mg

A single dose of metformin 500 mg tablets

DRUGsitagliptin phosphate (+) metformin hydrochloride

place holder - do not post

DRUGComparator: sitagliptin

A single 50 mg tablet of sitagliptin

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: metformin 1000 mg

A single dose of metformin 1000 mg tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 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 * Subject is willing to avoid strenuous physical activity during the study * Subject agrees to refrain from eating grapefruit or grapefruit products during the study

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 consumes excessive amounts of alcohol or caffeinated beverages * Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks * Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food * Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin * Subject is a regular user or past abuser of any illicit drugs * Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study. * Subject is a nursing mother

Design outcomes

Primary

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

Secondary

Measure	Time frame
Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets	72 hours post dose

Outcome results

None listed

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