A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets - Full Text View

Purpose

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).

Condition	Intervention	Phase
Type 2 Diabetes	Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: metformin 500mg Drug: Comparator: sitagliptin Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet Drug: Comparator: metformin 1000 mg Drug: Comparator: metformin 850 mg	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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. [ Time Frame: Up to 72 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Up to 72 hours postdose ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	October 2007
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Treatment A 50 mg sitagliptin and 500 mg metformin as individual tablets	Drug: sitagliptin phosphate (+) metformin hydrochloride place holder - do not post Drug: Comparator: metformin 500mg A single dose of metformin 500 mg tablet Other Name: Glucophage Drug: Comparator: sitagliptin A single dose of 50 mg sitagliptin tablet Other Name: Januvia
Experimental: Treatment B sitagliptin/metformin 50 mg/500 mg tablet	Drug: Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
Active Comparator: Treatment C 50 mg sitagliptin and 1000 mg metformin as individual tablets	Drug: Comparator: sitagliptin A single dose of 50 mg sitagliptin tablet Other Name: Januvia Drug: Comparator: metformin 1000 mg A single dose of metformin 1000 mg tablet Other Name: Glucophage
Experimental: Treatment D sitagliptin/metformin 50 mg/1000 mg tablet	Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
Active Comparator: Treatment E 50 mg sitagliptin and 850 mg metformin as individual tablets	Drug: Comparator: sitagliptin A single dose of 50 mg sitagliptin tablet Other Name: Januvia Drug: Comparator: metformin 850 mg A single dose of metformin 850 mg tablet Other Name: Glucophage
Experimental: Treatment F sitagliptin/metformin 50 mg/850 mg tablet	Drug: Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961480

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00961480 History of Changes
Other Study ID Numbers:	2009_636, MK0431A-095
Study First Received:	August 18, 2009
Last Updated:	April 7, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013