At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Cilostazol 100 mg tablets +1 moredrug
Likely dose
Cilostazol 100 mg tabletsfrom 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.
A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Cilostazol, 100 mg, Compared to an Equivalent Dose of a Commercially Available Reference Drug Product in 36 Fasted, Healthy, Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Cilostazol 100 mg tablets and Pletal® 100 mg tablets for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36 adult subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2003
Primary CompletionNov 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 6, 2009
Enrollment StartNov 1, 2003
Primary CompletionNov 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Cilostazol 100 mg tabletsdrug
1 x 100 mg
Pletal® 100 mg tabletsdrug
1 x 100 mg