Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03524963
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2018-05-01
Brief Title:
Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
Sponsor:
Bundang CHA Hospital
Organization:
Bundang CHA Hospital
Study Overview
Official Title:
A Randomized Open Label Multiple Does Crossover Study to Compare the SafetyTolerability and Pharmacokinetics Between Pleetal SR Cap and Cilostan CR Tab in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized open-label multiple-dose two-sequence two-period crossover study to to compare the safetytolerability 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None