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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Sitagliptin phosphate/metformin hydrochloride FDC; Drug: Sitagliptin phosphate; Drug: Metformin hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sita + Met then Sita/Met FDC; Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.	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.; Drug: Sitagliptin phosphate; Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.; Drug: Metformin hydrochloride; Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Active Comparator: Sita/Met FDC then Sita + Met; Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.	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.; Drug: Sitagliptin phosphate; Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.; Drug: Metformin hydrochloride; Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate
• Other Study ID Numbers: 0431A-080; MK-0431A-080 (Other Identifier: Merck protocol number); 2009_607 (Other Identifier: Merck registration number)