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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01112462 | To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine | PHASE1 | COMPLETED | 40 | — | — | Mar 1, 2010 | Jun 1, 2010 | Jul 10, 2012 | 1 | Ireland |
Pharmacokinetic measurements including: * Cmax (Maximum concentration) * AUC0-t (Area under the plasma concentration versus time curve from 0h to the lastmeasurable concentration) * AUC0-inf (Area under the plasma concentration versus time curve from 0h to infinity)
| Arm | Type | Description |
|---|---|---|
| Tablet | EXPERIMENTAL | Paracetamol 500 mg/Phenylephrine 5 mg tablet |
| Sachet | ACTIVE_COMPARATOR | Paracetamol 1000 mg/Phenylephrine 10 mg sachet |
| Name | Type | Description |
|---|---|---|
| Paracetamol 500 mg/Phenylephrine 5 mg tablets | DRUG | 2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period |
| Paracetamol 1000 mg/Phenylephrine 10 mg sachet | DRUG | 1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period |
Inclusion Criteria: * Healthy male and female * Caucasians * Aged between 18 and 50 years * BMI ≤ 30 kg/m2 * Clinically normal medical history * Physical normal examination * Normal laboratory test results Exclusion Criteria: * Pregnancy, lactation or intended pregnancy * Hypersensitivity to or i...