A Phase 1 interventional study of Cilostan CR Tab. and Pletaal SR Cap. in Peripheral Artery Disease, sponsored by Bundang CHA Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by Bundang CHA Hospital · Phase 1, Interventional, and Treatment
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
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 30 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Bundang CHA Hospital is the lead sponsor of 34 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2
Drug: Cilostan CR Tab. · Drug: Pletaal SR Cap.
Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2
Drug: Cilostan CR Tab. · Drug: Pletaal SR Cap.
Cilostan CR Tab. 200mg once a day for 5 days
Pletaal SR Cap. 200mg once a day for 5 days
Cmax
Maximal plasma concentration
Time frame: up to 24 hours after 1st dose
AUC0-24
Area under the time-concentration curve
Time frame: up to 24 hours after 1st dose
Cmax,ss
Maximal plasma concentration at steady-state
Time frame: up to 72 hours after 5th dose
AUCtau
Area under the time-concentration curve
Time frame: up to 24 hours after 5th dose
AE
Adverse events
Time frame: Up to 30 days after final dose
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Bundang CHA Hospital