Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
New Paracetamol · 1 trial · 1 indication
Blood samples were collected at the indicated time points for the analysis of AUC (0-tlast). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at the indicated time points for for the analysis of tmax. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at the indicated time points for for the analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Test Drug | EXPERIMENTAL | Participants will receive a single oral dose of either New Paracetamol Oral Suspension (24 mg/ml) or Panadol B\&I Oral Suspension (24 mg/ml paracetamol) on Day 1 (Period 1) and Day 4 (Period 2) under fasting conditions as per the randomization schedule. A wash out period of at least 72-hour will be maintained between each treatment period. |
| Reference Drug | ACTIVE_COMPARATOR | Participants will receive a single oral dose of either New Paracetamol Oral Suspension (24 mg/ml) or Panadol B\&I Oral Suspension (24 mg/ml paracetamol) on Day 1 (Period 1) and Day 4 (Period 2) under fasting conditions as per the randomization schedule. A wash out period of at least 72-hour will be maintained between each treatment period |
| Name | Type | Description |
|---|---|---|
| New Paracetamol Oral Suspension (24 mg/ml) | DRUG | After an overnight fasting for at least 10 hours, New Paracetamol Oral Suspension (24 mg/ml) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period. |
| Panadol B&I Oral Suspension (24 mg/ml paracetamol) | DRUG | After an overnight fasting for at least 10 hours, Panadol B\&I Oral Suspension (24 mg/ml paracetamol) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period. |
Inclusion Criteria: * Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * A participant who is willing and able to comply with scheduled visits, treatment ...
New Paracetamol is an investigational small molecule being developed for the treatment of pain. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
New Paracetamol is being developed by Haleon plc, a consumer healthcare company listed on the London Stock Exchange under the ticker HLN. The company is conducting clinical trials to evaluate this investigational pain medication.
New Paracetamol is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or other regulatory agencies. The drug is being studied in healthy volunteers to assess its bioequivalence and safety profile.
New Paracetamol has one completed Phase 1 clinical trial, NCT05022810, which was a bioequivalence study comparing a new paracetamol oral suspension 24mg/ml to the marketed Panadol Baby and Infant 24mg/ml suspension. The trial enrolled 61 healthy adult subjects in Czechia.
New Paracetamol is a new formulation of paracetamol, the active ingredient in Panadol. The Phase 1 trial NCT05022810 compared New Paracetamol oral suspension to the marketed Panadol Baby and Infant suspension to assess bioequivalence, meaning the new formulation is intended to deliver the same drug in a comparable manner.