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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961857
• Other study ID #: 0431A-048
• Secondary ID: MK0431A-0482009_
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2005
• Est. completion date: January 1, 2006

Study information

• Verified date: November 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 1, 2006
• Est. primary completion date: December 1, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• sitagliptin phosphate (+) metformin hydrochloride
place holder - do not post
• Comparator: metformin 500 mg
A single dose of metformin 500 mg tablets
• Comparator: sitagliptin
A single 50 mg tablet of sitagliptin
• Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
• Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
• Comparator: metformin 1000 mg
A single dose of metformin 1000 mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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