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

NCT ID: NCT00961857

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-01
• Study Completion Date: 2006-01-01

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).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Individual Tablets of 50 mg sitagliptin and 500 mg metformin

Group Type: ACTIVE_COMPARATOR

sitagliptin phosphate (+) metformin hydrochloride

Intervention Type: DRUG

place holder - do not post

Comparator: metformin 500 mg

Intervention Type: DRUG

A single dose of metformin 500 mg tablets

Comparator: sitagliptin

Intervention Type: DRUG

A single 50 mg tablet of sitagliptin

Treatment B

Sitagliptin/metformin 50 mg/500 mg tablet

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Treatment C

Individual Tablets of 50 mg sitagliptin and 1000 mg metformin

Group Type: ACTIVE_COMPARATOR

Comparator: sitagliptin

Intervention Type: DRUG

A single 50 mg tablet of sitagliptin

Comparator: metformin 1000 mg

Intervention Type: DRUG

A single dose of metformin 1000 mg tablets

Treatment D

sitagliptin/metformin 50 mg/1000 mg tablet

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

sitagliptin phosphate (+) metformin hydrochloride

place holder - do not post

Intervention Type: DRUG

Comparator: metformin 500 mg

A single dose of metformin 500 mg tablets

Intervention Type: DRUG

Comparator: sitagliptin

A single 50 mg tablet of sitagliptin

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Comparator: metformin 1000 mg

A single dose of metformin 1000 mg tablets

Intervention Type: DRUG

Other Intervention Names

Apotex; Apotex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Migoya EM, Miller JL, Gutierrez M, Zheng W, Johnson-Levonas AO, Liu Q, Matthews CZ, Wagner JA, Gottesdiener KM. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig. 2010;30(12):855-66. doi: 10.1007/BF03256914.

Reference Type: RESULT

PMID: 20923244 (View on PubMed)

Other Identifiers

MK0431A-048

Identifier Type: -

Identifier Source: secondary_id

2009_635

Identifier Type: -

Identifier Source: secondary_id

0431A-048

Identifier Type: -

Identifier Source: org_study_id