Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929201
• Other study ID #: 0431A-080
• Secondary ID: MK-0431A-0802009
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2009
• Last updated: July 22, 2015
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: July 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

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• is in good health

• is a nonsmoker

• is willing to follow all study guidelines

Exclusion Criteria:

• has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant

• is a nursing mother

• is unwilling to consume the required high-fat breakfast

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin phosphate/metformin hydrochloride FDC
Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.
• Sitagliptin phosphate
Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.
• Metformin hydrochloride
Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

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	Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin	Serum samples were used to determine the AUC from time 0 to infinity for metformin.	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose	No
Secondary	Peak Plasma Concentration (Cmax) of Metformin	Serum samples were used to determine the maximum concentration for metformin.	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose	No