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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961480
• Other study ID #: 0431A-095
• Secondary ID: MK0431A-0952009_
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2009
• Last updated: June 8, 2015
• Start date: October 2007
• Est. completion date: November 2007

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 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

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• sitagliptin phosphate (+) metformin hydrochloride
place holder - do not post
• Comparator: metformin 500mg
A single dose of metformin 500 mg tablet
• Comparator: sitagliptin
A single dose of 50 mg sitagliptin tablet
• 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: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
• Comparator: metformin 1000 mg
A single dose of metformin 1000 mg tablet
• Comparator: metformin 850 mg
A single dose of metformin 850 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No