NCT03524963

Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea

A Randomized, Open Label, Multiple Does, Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between Pleetal SR Cap. and Cilostan CR Tab. in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bundang CHA Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers

Detailed description

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing (Day -1). From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or Cilostan CR Tab. 200mg once a day). Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72 hours after 5th study drug dosing. After 9 days of washout period (Day 15), Subjects will be dosed study drug and pharmacokinetic samplings will be done by crossover manner.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Cilostan CR Tab.	Cilostan CR Tab. 200mg once a day for 5 days
DRUG	Pletaal SR Cap.	Pletaal SR Cap. 200mg once a day for 5 days

Timeline

• Start date: 2017-08-07
• Primary completion: 2018-05-30
• Completion: 2018-06-30
• First posted: 2018-05-15
• Last updated: 2018-07-24

Locations

1 site across 1 country: South Korea