Skip to main content
OpenTrials
Completed

NCT Number: NCT00961480

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate (+) metformin hydrochloride

Drug

place holder - do not post

Comparator: metformin 500mg

Drug

A single dose of metformin 500 mg tablet

Other names: Glucophage

Comparator: Sitagliptin

Drug

A single dose of 50 mg sitagliptin tablet

Other names: Januvia

Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet

Drug

A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet

Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Drug

A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet

Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Drug

A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet

Comparator: metformin 1000 mg

Drug

A single dose of metformin 1000 mg tablet

Other names: Glucophage

Comparator: metformin 850 mg

Drug

A single dose of metformin 850 mg tablet

Other names: Glucophage

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 19, 2009
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.