Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-06 @ 4:36 PM
Study NCT ID:
NCT02902302
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet
Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Organization:
Study Overview
Official Title:
Bioequivalence Study of a New Formulation of Ibuprofen 400 mg/10 mL Oral Suspension vs. the Reference Product MOMENTACT 400 mg Film-coated Tablet in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-07
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:
The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg film-coated tablet, when administered under fasting conditions as single oral dose to healthy male and female volunteers, in two consecutive study periods.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CRO-PK-15-307 | OTHER | CROSS Research S.A., Phase I Unit | View |