clinical trial · NCT05191862
Bioequivalence Study of PMR Compared to Cilostazol IR Tablets in Healthy Volunteers
Genovate Biotechnology Co., Ltd.,·phase1·terminated·n = 19
Intermittent ClaudicationCilostazol 100 mgPMR 135 mg
brief 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.
started
Apr 23, 2022
primary completion
May 4, 2022
completion
May 7, 2022
last updated
Mar 13, 2025
official title
An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol