Back to resultsComparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
Primary Purpose
Peripheral Artery Disease
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostan CR Tab.
Pletaal SR Cap.
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
Eligibility 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)
Sites / Locations
- CHA Bundang Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2
Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
Outcomes
Primary Outcome Measures
Cmax
Maximal plasma concentration
AUC0-24
Area under the time-concentration curve
Cmax,ss
Maximal plasma concentration at steady-state
AUCtau
Area under the time-concentration curve
Secondary Outcome Measures
AE
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03524963
Brief Title
Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
Intervention Type
Drug
Intervention Name(s)
Cilostan CR Tab.
Intervention Description
Cilostan CR Tab. 200mg once a day for 5 days
Intervention Type
Drug
Intervention Name(s)
Pletaal SR Cap.
Intervention Description
Pletaal SR Cap. 200mg once a day for 5 days
Primary Outcome Measure Information:
Title
Cmax
Description
Maximal plasma concentration
Time Frame
up to 24 hours after 1st dose
Title
AUC0-24
Description
Area under the time-concentration curve
Time Frame
up to 24 hours after 1st dose
Title
Cmax,ss
Description
Maximal plasma concentration at steady-state
Time Frame
up to 72 hours after 5th dose
Title
AUCtau
Description
Area under the time-concentration curve
Time Frame
up to 24 hours after 5th dose
Secondary Outcome Measure Information:
Title
AE
Description
Adverse events
Time Frame
Up to 30 days after final dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam
ZIP/Postal Code
13496
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
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