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

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524963
• Other study ID #: 021-402-00016
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Cilostan CR Tab.
Cilostan CR Tab. 200mg once a day for 5 days
• Pletaal SR Cap.
Pletaal SR Cap. 200mg once a day for 5 days

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximal plasma concentration	up to 24 hours after 1st dose
Primary	AUC0-24	Area under the time-concentration curve	up to 24 hours after 1st dose
Primary	Cmax,ss	Maximal plasma concentration at steady-state	up to 72 hours after 5th dose
Primary	AUCtau	Area under the time-concentration curve	up to 24 hours after 5th dose
Secondary	AE	Adverse events	Up to 30 days after final dose