Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
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
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2017
CompletedFirst Submitted
Initial submission to the registry
May 1, 2018
CompletedFirst Posted
Study publicly available on registry
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJuly 24, 2018
July 1, 2018
10 months
May 1, 2018
July 22, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Cmax
Maximal plasma concentration
up to 24 hours after 1st dose
AUC0-24
Area under the time-concentration curve
up to 24 hours after 1st dose
Cmax,ss
Maximal plasma concentration at steady-state
up to 72 hours after 5th dose
AUCtau
Area under the time-concentration curve
up to 24 hours after 5th dose
Secondary Outcomes (1)
AE
Up to 30 days after final dose
Study Arms (2)
Sequence A
EXPERIMENTALCilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2
Sequence B
EXPERIMENTALPletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects aged 20 - 45 years
- BMI (body mass index) between 18.0 and 27.0
- Agreement with written informed consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHA Bundang Medical Center
Seongnam, 13496, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 1, 2018
First Posted
May 15, 2018
Study Start
August 7, 2017
Primary Completion
May 30, 2018
Study Completion
June 30, 2018
Last Updated
July 24, 2018
Record last verified: 2018-07