Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paracetamol/Phenylephrine · 1 trial · 1 indication
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...
Paracetamol/Phenylephrine is a small molecule combination drug being developed for respiratory tract infections. It is currently in Phase 1 clinical development as an investigational product. The drug is being studied for its potential use in treating conditions related to respiratory tract infections.
Paracetamol/Phenylephrine is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for respiratory tract infections.
Paracetamol/Phenylephrine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for respiratory tract infections, with one completed Phase 1 trial.
Paracetamol/Phenylephrine has one completed clinical trial, NCT01112462, which was a Phase 1 study titled 'To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine'. The trial enrolled 40 participants in Ireland and was active-controlled, though it was not double-blinded.
Paracetamol/Phenylephrine is a combination drug containing both paracetamol and phenylephrine as active ingredients. It is being developed as a fixed-dose combination for respiratory tract infections, distinct from products containing only one of these components.