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NCT05191862 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of PMR Compared to Cilostazol IR Tablets in Healthy Volunteers
A Phase 1 study, sponsored by Genovate Biotechnology Co., Ltd.,.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05191862 is a Phase 1 study that was terminated before completion, run by Genovate Biotechnology Co., Ltd.,. The registered enrollment target is 19 participants.
The verdict
NCT05191862, a Phase 1 study, was terminated before completion, sponsored by Genovate Biotechnology Co., Ltd.,.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 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 100 mg
- DRUG PMR 135 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-04-23 |
| Est. Completion | 2022-05-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05191862
The ClinicalTrials.gov registry entry for NCT05191862 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 19 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 100 mg is the first listed.
NCT05191862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05191862 about?
NCT05191862 is a clinical study titled "Bioequivalence Study of PMR Compared to 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 in...
What is the current status of trial NCT05191862?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2022-04-23. Estimated completion is 2022-05-07.
What interventions are being tested in trial NCT05191862?
The interventions under investigation include: Cilostazol 100 mg (DRUG), PMR 135 mg (DRUG).
Who is sponsoring clinical trial NCT05191862?
This trial is sponsored by Genovate Biotechnology Co., Ltd.,, which has 5 total clinical trials registered on ClinicalTrials.gov.
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