Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Panadol B&I · 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 ...
Panadol B&I is a paracetamol oral suspension, 24 mg per ml, developed by Haleon plc for pain. It is a small molecule medicine. It has been studied in a Phase 1 bioequivalence trial in healthy adult volunteers, comparing it with the marketed Panadol Baby and Infant 24 mg/ml oral suspension.
Panadol B&I is intended for pain. Its listed therapeutic area is pain, and the single clinical trial in it enrolled healthy adult volunteers rather than patients with a specific painful condition. The trial's listed condition was pain, and the study was designed to compare the new suspension with the marketed paracetamol oral suspension.
Panadol B&I is developed by Haleon plc, which trades under the ticker HLN. Haleon is the company behind the Panadol brand of paracetamol products. The asset covered here is the Panadol B&I oral suspension formulation at 24 mg per ml.
Panadol B&I is in Phase 1. Its only listed trial is a Phase 1 bioequivalence study, and that trial is completed. There are no active trials of Panadol B&I recorded, so the asset is not currently in an ongoing clinical study.
Panadol B&I has been studied in one trial, NCT05022810, titled a bioequivalence study of a new paracetamol oral suspension 24 mg/ml compared to the marketed paracetamol oral suspension (Panadol Baby and Infant 24 mg/ml) in healthy adult subjects. It was a completed Phase 1 randomized, active-controlled study with 61 participants in Czechia.