Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test Product · 1 trial · 1 indication
AUC(0-t) will be defined as the area under the plasma concentration Vs. time curve calculated from time 0 to the last measurable sampling time point, t and will be computed using the linear trapezoidal rule. Blood samples will be collected at indicated time points for the analysis of AUC(0-t).
AUC0-inf will be defined as the area under the plasma concentration Vs. time curve calculated from time 0 to infinity. AUC0-inf equal to (=) AUC0-t addition (+) Clast divided by (/) λz, where Clast will be the concentration at the last measurable sampling time point and λz will be the terminal elimination rate constant. Blood samples will be collected at indicated timepoints for the analysis of AUC0-inf.
Cmax will be defined as the maximum observed plasma concentration for Test Product. Blood samples will be collected at indicated timepoints for the analysis of Cmax.
Tmax will be defined as the time to reach the maximum observed plasma concentration for Test Product. Blood samples will be collected at indicated timepoints for the analysis of Tmax.
λz will be defined as the apparent terminal elimination rate constant determined by log-linear regression. The regression will generally involve at least 3 consecutive measurable concentrations that decrease over time, excluding Cmax. Blood samples will be collected at indicated timepoints for the analysis of Cmax.
t1/2 will be defined as the elimination half-life computed as t1/2 = natural logarithm (ln)(2)/λz. Blood sample will be collected at indicated timepoints for analysis of t1/2.
Vz/F will be defined as apparent volume of distribution and will be calculated by the dose administered/ (λz multiply by (×) AUC0-inf). Blood sample will be collected at indicated timepoints for the analysis of Vz/F.
Cl/F will be defined as apparent total clearance and will be calculated by the dose administered/AUC0-inf. Blood sample will be collected at indicated timepoints for the analysis of Cl/F.
Vz/F/lbs will be defined as apparent volume of distribution, adjusted for body size. Blood sample will be collected at indicated timepoints for the analysis of Vz/F/lbs.
Cl/F/lbs will be defined as apparent total clearance, adjusted for body size. Blood sample will be collected at indicated timepoints for the analysis of Cl/F/lbs.
| Arm | Type | Description |
|---|---|---|
| Test Product | EXPERIMENTAL | Participants will receive a single dose (weight-based) of Test Product orally using 10 mL oral dosing syringes followed by 4 ounce (oz) ambient temperature water. |
| Name | Type | Description |
|---|---|---|
| Test Product | DRUG | Liquid suspension FDC IBU 62.5 mg / APAP 125 mg |
Inclusion Criteria: * Participants meeting at least one of the following criteria: 1. Participant with at least one acute, painful condition (e.g., minor aches and pains due to headache, menstruation, toothache, sports injuries, etc.) requiring use of an oral over the counter (OTC) analgesic wit...
Test Product is an investigational small molecule being developed for the treatment of pain. It is currently in Phase 1 clinical development.
Test Product is being developed by Haleon plc, a company listed on the stock exchange under the ticker HLN.
Test Product is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.
Test Product is being studied in a Phase 1 clinical trial with the identifier NCT07632274. This trial is recruiting participants in the United States and is evaluating the drug in children aged 6 to 11 years.
No, the current clinical trial for Test Product is not randomized and does not use a control group. It is an uncontrolled study with an estimated enrollment of 12 participants.