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Phosphodiesterase Inhibitor
Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Genovate Biotechnology Co., Ltd.,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
Eligible Conditions
- Intermittent Claudication
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment2 Interventions
Treatment TRTR
Group II: Sequence 1Experimental Treatment2 Interventions
Treatment RTRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cilostazol 100 mg
2019
Completed Phase 1
~50
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Genovate Biotechnology Co., Ltd.,Lead Sponsor
13 Previous Clinical Trials
749 Total Patients Enrolled
4 Trials studying Intermittent Claudication
114 Patients Enrolled for Intermittent Claudication