MedTrace Logo

Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

NCT03864666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-05-14

No results posted yet for this 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.

Conditions

  • Intermittent Claudication

Interventions

DRUG

Cilostazol 100 mg

One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg)

DRUG

PMR 200 mg

Two PMR 200 mg at 08:00, single oral dose (total daily dose of 400 mg)

Sponsors & Collaborators

  • Genovate Biotechnology Co., Ltd.,

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2019-03-19
Completion
2019-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864666 on ClinicalTrials.gov