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

Bundang CHA Hospital

Status and phase: Completed; Phase 1

Conditions: Peripheral Artery Disease

Treatments: Drug: Cilostan CR Tab.; Drug: Pletaal SR Cap.

Study type: Interventional

Funder types: Other

Identifiers

NCT03524963

021-402-00016

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Sequence A

Experimental group

Description:

Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2

Treatment:

Drug: Pletaal SR Cap.

Drug: Cilostan CR Tab.

Sequence B

Experimental group

Description:

Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2

Treatment:

Drug: Pletaal SR Cap.

Drug: Cilostan CR Tab.