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

Phase 1

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Cilostan CR Tab.; Drug: Pletaal SR Cap.

• Registration Number: NCT03524963
• Lead Sponsor: Bundang CHA Hospital

Brief 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.

Study Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-13
• Study First Posted: 2018-05-15
• Primary Completion: 2018-05-30
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-22
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Healthy male subjects aged 20 - 45 years
• BMI (body mass index) between 18.0 and 27.0
• Agreement with written informed consent

Exclusion Criteria

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
• Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin > 1.5 x UNL)
• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab
• Taking OTC (Over the counter) medicine including oriental medicine within 7 days
• Clinically significant allergic disease
• Subject with known for hypersensitivity reaction to Cilostazol
• Previous whole blood donation within 60 days or component blood donation within 30 days
• Previous participation of other trial within 90 days
• Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	Pletaal SR Cap.	Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
Sequence B	Cilostan CR Tab.	Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
Sequence A	Cilostan CR Tab.	Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2
Sequence A	Pletaal SR Cap.	Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2

Primary Outcome Measures

Name	Time	Method
AUC0-24	up to 24 hours after 1st dose	Area under the time-concentration curve
Cmax	up to 24 hours after 1st dose	Maximal plasma concentration
Cmax,ss	up to 72 hours after 5th dose	Maximal plasma concentration at steady-state
AUCtau	up to 24 hours after 5th dose	Area under the time-concentration curve

Secondary Outcome Measures

Name	Time	Method
AE	Up to 30 days after final dose	Adverse events

Trial Locations

Locations (1)

CHA Bundang Medical Center; 🇰🇷 Seongnam, Korea, Republic of