At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Sitagliptin phosphate anhydrous formulation +1 moredrug
Likely dose
Sitagliptin phosphate anhydrous formulation 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Sitagliptin phosphate anhydrous formulation and Comparator: sitagliptin phosphate monohydrate form for Type 2 Diabetes Mellitus. Completed, enrolled 12 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionSep 2004
Study CompletionNov 2004
First PostedJul 2009
TodayJul 2026
First PostedJul 23, 2009
Enrollment StartAug 1, 2004
Primary CompletionSep 1, 2004
Study CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago
Interventions
Sitagliptin phosphate anhydrous formulationdrug
Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
Comparator: sitagliptin phosphate monohydrate formdrug
Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.