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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 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.

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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

FieldValue
Enrollment Target 21 participants
Start Date 2018-03-06
Est. Completion 2018-06-07
Phase Phase 1

What the Registry Record Tells You About NCT03480321

The ClinicalTrials.gov registry entry for NCT03480321 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 214-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (90% lower). The listed sponsor is Genovate Biotechnology Co., Ltd.,, which has 5 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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