Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03561558 | Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions | PHASE1 | COMPLETED | 30 | — | — | Jun 11, 2018 | Jun 25, 2018 | Nov 1, 2018 | 1 | Russia |
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...