Skip to main content
OpenTrials
Completed

NCT Number: NCT00944450

Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.

Completed

Looking for future studies?

Notify Me

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–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

  • Subject is in good health
  • Female subjects must have a negative pregnancy test
  • Subject is within 30% of ideal body weight
  • Subject does not smoke
  • Subject agrees to follow the study guidelines

Exclusion criteria

  • Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
  • Subject has a history of hypoglycemia
  • Subject has a history of any hepatic disease
  • Subject is taking any oral, parenteral, topical or implantable contraceptives

Treatment and study plan

Sitagliptin phosphate anhydrous formulation

Drug

Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.

Comparator: sitagliptin phosphate monohydrate form

Drug

Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.

Primary outcomes

  1. Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

    Time frame: Through 72 Hours Following the Administration of the Medication

    Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

  2. Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

    Time frame: Through 72 Hours Following the Administration of the Medication

    Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of Tablet Formulations Containing the Anhydrous and Monohydrate (FMI) Forms of MK0431

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jul 23, 2009
Registry last updated
Aug 19, 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.