Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT02075268
Status:
UNKNOWN
Last Update Posted:
2014-03-04
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
An Open Label, Single Dose Study to Characterize the Pharmacokinetics and Pharmacodynamics of Prasugrel in Healthy Male Adult Subjects
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
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:
PRAS-AM
Brief Summary:
An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects
Detailed Description:
1. Screening
2. Enrollment and treatment randomization
3. Confinement to Research Unit from day - 1 to day 2
4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)
5. Drug administration : Overnight Fasting
6. Blood sampling for PK, PD and genotyping
1. PK: up to 24 hours after dosing
2. PD: up to 72 hours after dosing
2. Enrollment and treatment randomization
3. Confinement to Research Unit from day - 1 to day 2
4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)
5. Drug administration : Overnight Fasting
6. Blood sampling for PK, PD and genotyping
1. PK: up to 24 hours after dosing
2. PD: up to 72 hours after dosing
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-0064 | OTHER | Institutional review board of Asan Medical Center | View |