Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-22 @ 2:31 PM
Study NCT ID:
NCT01734902
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2012-11-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide, Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Study)
Status:
COMPLETED
Status Verified Date:
2019-04
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 current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-003720-20 | EUDRACT_NUMBER | EudraCT | View |