Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-04-15 @ 4:58 PM
Study NCT ID:
NCT02273557
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Bioavailability of Dipyridamole of Asasantin p.o. (Extended Release 200 mg Dipyridamole/25 mg ASA) in Three Experimental Formulations (Given BID Over 3 Days Each) Relative to the Standard Formulation After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Persantine/25 mg ASA [Asasantin ER] in Healthy Male Subjects. Four-way, Change-over, Randomised, Open
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: