At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Cilostazol 50 mg Tablets +1 moredrug
Likely dose
Cilostazol 50 mg Tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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A Comparative Bioavailability Study of Cilostazol Tablets, 50mg, Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Cilostazol 50 mg Tablets and Cilostazol (Pletal®) 50 mg Tablets for Therapeutic Equivalency, Healthy. Completed, enrolled 32 participants.
Detailed Summary
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTherapeutic Equivalency, Healthy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
Primary CompletionJul 2004
First PostedMay 2008
TodayJul 2026
First PostedMay 28, 2008
Enrollment StartJun 1, 2004
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 18.1 years ago
Interventions
Cilostazol 50 mg Tabletsdrug
Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours
Cilostazol (Pletal®) 50 mg Tabletsdrug
Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.