Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paracetamol ODT · 1 trial · 2 indications
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations). Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast. PK parameters were determined by non-compartmental analysis.
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations. Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast). PK parameters were determined by non-compartmental analysis.
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Test Product | EXPERIMENTAL | Participants will be randomly assigned as per cross-over design to receive oral administration of one paracetamol ODT (test product) on day 1 of period 1, one Alvedon film-coated tablet (reference product 1) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days). |
| Reference Product 1 | ACTIVE_COMPARATOR | Participants will be randomly assigned as per cross-over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days). |
| Reference Product 2 | ACTIVE_COMPARATOR | Participants will be randomly assigned as per cross-over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, and one paracetamol ODT (test product) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days). |
| Name | Type | Description |
|---|---|---|
| Paracetamol ODT | DRUG | Experimental Paracetamol 500 mg ODT |
| Alvedon film-coated tablet | DRUG | Marketed Paracetamol 500 mg film-coated tablet |
| Panadol film-coated Tablet | DRUG | Marketed Paracetamol 500 mg film-coated tablet |
Inclusion Criteria: * Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants participating in the clinical trial. * Sex: male/female. * Age: 18 to 55 years (including) * B...
Paracetamol ODT is used for fever and pain. It is being developed as an orally disintegrating tablet formulation of paracetamol, a small molecule. The drug is currently in Phase 1 clinical development for the treatment of fever.
Paracetamol ODT is being developed by Haleon plc, a company listed on the stock exchange under the ticker HLN. The drug is in Phase 1 clinical development for the treatment of fever.
Paracetamol ODT is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed for this drug.
Paracetamol ODT has one completed clinical trial, identified as NCT06855576. This was a Phase 1 bioequivalence study with oral single dose administration in healthy adult subjects under fasting conditions, conducted in Germany with 54 participants.
Paracetamol ODT is an orally disintegrating tablet formulation of paracetamol, the active ingredient. It is designed to dissolve quickly in the mouth without water. The drug is being developed for fever and pain.