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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2018-06-30

Brief Summary

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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

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Detailed Description

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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

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

Cilostan CR Tab.

Intervention Type DRUG

Cilostan CR Tab. 200mg once a day for 5 days

Pletaal SR Cap.

Intervention Type DRUG

Pletaal SR Cap. 200mg once a day for 5 days

Sequence B

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

Group Type EXPERIMENTAL

Cilostan CR Tab.

Intervention Type DRUG

Cilostan CR Tab. 200mg once a day for 5 days

Pletaal SR Cap.

Intervention Type DRUG

Pletaal SR Cap. 200mg once a day for 5 days

Interventions

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Cilostan CR Tab.

Cilostan CR Tab. 200mg once a day for 5 days

Intervention Type DRUG

Pletaal SR Cap.

Pletaal SR Cap. 200mg once a day for 5 days

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes