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NCT03480321 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
A Phase 1 study of Intermittent Claudication, sponsored by Genovate Biotechnology Co., Ltd.,.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03480321: Completed Phase 1 study of Intermittent Claudication, sponsored by Genovate Biotechnology Co., Ltd.,.
NCT03480321 is a Phase 1 study of Intermittent Claudication that has completed, run by Genovate Biotechnology Co., Ltd.,. The registered enrollment target is 21 participants, below the 214-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03480321, a Phase 1 study of Intermittent Claudication, has completed, sponsored by Genovate Biotechnology Co., Ltd.,.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is designed to evaluate the bioequivalency between the test formulations 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.
Conditions Studied
Interventions
- DRUG Cilostazol 100 mg
- DRUG PMR 150 mg
- DRUG PMR 200 mg
Study Locations (1)
Missouri
- Bio-Kinetic Clinical Applications, LLC - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-03-06 |
| Est. Completion | 2018-06-07 |
| Phase | Phase 1 |
What the finished NCT03480321 record still lists
NCT03480321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 214-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Intermittent Claudication appearing as the primary indexed condition, and to 3 interventions - of which Cilostazol 100 mg is the first listed.
NCT03480321 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03480321 about?
NCT03480321 is a clinical study titled "Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers". The study is designed to evaluate the bioequivalency between the test formulations 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 su...
What is the current status of trial NCT03480321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-03-06. Estimated completion is 2018-06-07.
What conditions does trial NCT03480321 study?
This clinical trial studies the following conditions: Intermittent Claudication.
What interventions are being tested in trial NCT03480321?
The interventions under investigation include: Cilostazol 100 mg (DRUG), PMR 150 mg (DRUG), PMR 200 mg (DRUG).
Who is sponsoring clinical trial NCT03480321?
This trial is sponsored by Genovate Biotechnology Co., Ltd.,, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03480321 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03480321's enrollment target sits among peer trials
21 12th of 11 the lowest of 11 other Intermittent Claudication trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intermittent Claudication trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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