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Completed

NCT Number: NCT00961857

A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)

A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).

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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–45 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
  • Subject is willing to avoid strenuous physical activity during the study
  • Subject agrees to refrain from eating grapefruit or grapefruit products during the study

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 consumes excessive amounts of alcohol or caffeinated beverages
  • Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
  • Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
  • Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
  • Subject is a regular user or past abuser of any illicit drugs
  • Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
  • Subject is a nursing mother

Treatment and study plan

sitagliptin phosphate (+) metformin hydrochloride

Drug

place holder - do not post

Comparator: metformin 500 mg

Drug

A single dose of metformin 500 mg tablets

Other names: Apotex

Comparator: Sitagliptin

Drug

A single 50 mg tablet of sitagliptin

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: metformin 1000 mg

Drug

A single dose of metformin 1000 mg tablets

Other names: Apotex

Primary outcomes

  1. The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets

    Time frame: 72 hours post dose

Secondary outcomes

  1. Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets

    Time frame: 72 hours post dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Aug 19, 2009
Registry last updated
Nov 13, 2019

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.

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