Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT01383395
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cilostazol on the Pharmacokinetics of Simvastatin
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2012-05
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:
To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.
Detailed Description:
Eligibility for participation of this study was 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 were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: