Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nurofen for Children · 1 trial · 1 indication
Peak Plasma Concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Ibuprofen D, oral suspension | EXPERIMENTAL | Ibuprofen oral suspension, 200 mg/ 5 ml is the test product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (5 ml containing 200 mg of ibuprofen) of suspension. |
| Nurofen® for Children, oral suspension | ACTIVE_COMPARATOR | Nurofen® for Children oral suspension, 100 mg/ 5 ml is the reference product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (10 ml containing 200 mg of ibuprofen) of suspension. |
| Name | Type | Description |
|---|---|---|
| Ibuprofen D | DRUG | Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus |
| Nurofen® for Children | DRUG | Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK |
Inclusion Criteria: 1. Healthy adult human subjects, aged between 18 to 45 years. 2. Subjects with Body Mass Index (BMI) 18.5 to 30 kg/m2. 3. Female subjects with a negative pregnancy test. 4. Non-lactating females. 5. If subject is a female and is of child bearing potential, she should be practici...
Nurofen for Children is an oral suspension of ibuprofen being studied in healthy volunteers. It is a small molecule drug developed by Ligand Pharmaceuticals Incorporated (LGND). The drug is currently in Phase 1 clinical development.
Nurofen for Children is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The drug is a small molecule oral suspension of ibuprofen.
Nurofen for Children is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Nurofen for Children has one completed clinical trial, NCT03561558, a Phase 1 bioequivalence study in healthy volunteers under fasting conditions. The study enrolled 30 participants in Russia and was active-controlled.
Nurofen for Children is an oral suspension containing ibuprofen, specifically 100 mg/5 ml. It is being studied for bioequivalence to a reference ibuprofen oral suspension of 200 mg/5 ml.