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NCT05466734 · ClinicalTrials.gov registry record · Phase 1
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
A Phase 1 study, sponsored by Genovate Biotechnology Co., Ltd.,.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT05466734 is a Phase 1 study that has completed, run by Genovate Biotechnology Co., Ltd.,. The registered enrollment target is 25 participants.
The verdict
NCT05466734, a Phase 1 study, has completed, sponsored by Genovate Biotechnology Co., Ltd.,.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cilostazol Tablet 100 mg
- DRUG PMR Tablet 135 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05466734
The ClinicalTrials.gov registry entry for NCT05466734 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genovate Biotechnology Co., Ltd.,, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cilostazol Tablet 100 mg is the first listed.
NCT05466734 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05466734 about?
NCT05466734 is a clinical study titled "BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers". 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 i...
What is the current status of trial NCT05466734?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-07-05. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT05466734?
The interventions under investigation include: Cilostazol Tablet 100 mg (DRUG), PMR Tablet 135 mg (DRUG).
Who is sponsoring clinical trial NCT05466734?
This trial is sponsored by Genovate Biotechnology Co., Ltd.,, which has 5 total clinical trials registered on ClinicalTrials.gov.
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