Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
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
3 other identifiers
interventional
12
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes-mellitus
Started Aug 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedResults Posted
Study results publicly available
April 27, 2010
CompletedAugust 19, 2015
August 1, 2015
1 month
July 21, 2009
February 24, 2010
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
1
ACTIVE COMPARATORSitagliptin anhydrous formulation
2
ACTIVE COMPARATORSitagliptin monohydrate FMI formulation
Interventions
Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
August 1, 2004
Primary Completion
September 1, 2004
Study Completion
November 1, 2004
Last Updated
August 19, 2015
Results First Posted
April 27, 2010
Record last verified: 2015-08