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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524963
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Doo-Yeoun Cho, M.D., Bundang CHA Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: Cilostan CR Tab. Drug: Pletaal SR Cap. Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : June 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence A
Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2
 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
Experimental: Sequence B
Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
 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


Outcome Measures
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Primary Outcome Measures :
  1. Cmax [ Time Frame: up to 24 hours after 1st dose ]
    Maximal plasma concentration

  2. AUC0-24 [ Time Frame: up to 24 hours after 1st dose ]
    Area under the time-concentration curve

  3. Cmax,ss [ Time Frame: up to 72 hours after 5th dose ]
    Maximal plasma concentration at steady-state

  4. AUCtau [ Time Frame: up to 24 hours after 5th dose ]
    Area under the time-concentration curve


Secondary Outcome Measures :
  1. AE [ Time Frame: Up to 30 days after final dose ]
    Adverse events


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524963


Locations
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Korea, Republic of
CHA Bundang Medical Center
Seongnam, Korea, Republic of, 13496
Sponsors and Collaborators
Bundang CHA Hospital
More Information
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Responsible Party: Doo-Yeoun Cho, M.D., Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT03524963    
Other Study ID Numbers: 021-402-00016
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases