Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-29 @ 5:49 PM
Study NCT ID:
NCT07036861
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
Sponsor:
Berlin-Chemie AG Menarini Group
Organization:
Study Overview
Official Title:
A Comparative Bioavailability of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Reference Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension in Healthy Male and Female Adult Subjects Under Fasting Conditions: an Open-label, Randomized, Single-dose, Three-period, Three-treatment, Three-sequence Crossover Study
Status:
COMPLETED
Status Verified Date:
2025-05
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:
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by the body, broken down, and how quickly it was removed from the body.
Detailed Description:
In this Phase 1 study, two test medications (reformulated Ibuprofen 2% oral suspension and Ibuprofen 4% oral suspension) were compared with the reference medication (Ibuprofen 4% oral suspension marketed under the trade name Nurofen dla dzieci Forte pomarańczowy 40 mg/mL, oral suspension) in terms of bioequovalence of the tested formulations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| 2023-503703-28 | EUDRACT_NUMBER | None | View |