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Completed

NCT Number: NCT00929201

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus 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

  • 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

Treatment and study plan

Sitagliptin phosphate/metformin hydrochloride FDC

Drug

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

sitagliptin phosphate

Drug

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Metformin Hydrochloride

Drug

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Primary outcomes

  1. Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin

    Time frame: 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

    Serum samples were used to determine the AUC from time 0 to infinity for metformin.

Secondary outcomes

  1. Peak Plasma Concentration (Cmax) of Metformin

    Time frame: 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

    Serum samples were used to determine the maximum concentration for metformin.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 26, 2009
Registry last updated
Aug 13, 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.

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