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.

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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–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

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)
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.

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

Completed