Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-10 @ 3:45 PM
Study NCT ID:
NCT03280095
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects
Sponsor:
Galen Limited
Organization:
Study Overview
Official Title:
A Randomised, Open-label, Three-treatment, Single Dose, Crossover Study Investigating the Bioequivalence of Co-codamol 15/500mg Capsules With a Co-codamol 30/500mg Tablet in Healthy Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2017-09
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 purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product).
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 |
|---|---|---|---|---|
| 2014-003334-12 | EUDRACT_NUMBER | None | View |