Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT02222961
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2014-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours
Status:
COMPLETED
Status Verified Date:
2014-08
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 the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers
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?: