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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944450
• Other study ID #: 0431-027
• Secondary ID: MK0431-0272009_6
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2009
• Last updated: August 18, 2015
• Start date: August 2004
• Est. completion date: November 2004

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin phosphate anhydrous formulation
Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
• Comparator: sitagliptin phosphate monohydrate form
Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Through 72 Hours Following the Administration of the Medication	No
Primary	Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)	Through 72 Hours Following the Administration of the Medication	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site