Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-22 @ 7:59 AM
Study NCT ID:
NCT02194257
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2014-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Metabolism and Pharmacokinetics of Ambroxol in Healthy Male Volunteers
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Investigation of the Metabolism and Pharmacokinetics of an Open Label Single Dose of 20 mg Ambroxol Administered as a Lozenge Together With an Oral Solution of 0.4 mg [14C]-Ambroxol in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Study to determine the basic pharmacokinetics of ambroxol and \[14C\]-radioactivity including mass balance, excretion pathways and complete metabolism in healthy male volunteers following administration of a lozenge of 20 mg ambroxol together with an oral solution of 0.4 mg \[14C\]-ambroxol labelled in two different positions
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?: