Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paracetamol formulation 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Paracetamol formulation 1 | OTHER | Higher dose level of marketed paracetamol (compared to the other dosage arm) |
| Paracetamol formulation 2 | OTHER | Lower paracetamol concentrations |
| Name | Type | Description |
|---|---|---|
| Paracetamol formulation 1 | DRUG | formulation 1 |
| Paracetamol formulation 2 | DRUG | Formulation 2 |
Inclusion Criteria: * Males in good general heatlh and Body Mass Index between 19-28 kg/m2 Exclusion Criteria: * Disease 1. Current liver impairment, renal impairment, history of or active gastrointestinal ulcers, uncontrolled hypertension, haemophilia or other bleeding disorders. 2. Current...
Paracetamol is used for pain, common cold, fever, and analgesia. It has been studied in conditions including pain, headache disorders, and osteoarthritis. The drug is also evaluated in healthy volunteers for pharmacokinetic studies.
Paracetamol is developed by GSK plc, which trades under the ticker GSK. The company has conducted clinical trials for this small molecule drug across multiple indications.
Paracetamol is in Phase 1 clinical development. It has completed two Phase 1 trials and one Phase 3 trial. The drug remains investigational and is not approved for any indication.
Paracetamol has completed clinical trials including NCT01551797, a pharmacokinetic study comparing sustained release and standard formulations, and NCT01568749, investigating extended release formulations. NCT01767428 compared two formulations, and NCT02311881 was a 12-week efficacy study in osteoarthritis patients.
Paracetamol is the generic name for the drug also known as acetaminophen in some regions. It is a small molecule used for pain and fever relief, developed by GSK plc.