The purpose of this study will be to characterize the pharmacokinetic (PK) profile of the Fixed-Dose Combination (FDC) IBU 62.5 milligram (mg)/APAP 125 mg per 5 milliliter (mL) suspension in children 6 to 11 years of age, inclusive, to satisfy Pediatric Research Equity Act (PREA) requirements.
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 within the previous 4 weeks (but not within the 48 hours prior to Day 1, Hour 0 investigational product dosing).
Participant has undergone a non-surgical orthodontic or dental procedure (e.g., placement of an orthodontic appliance or adjustment of braces) within 24 hours prior to dosing.
Participant with post-vaccination pain (post-injection site redness/soreness, joint pain) and/or fever at time of investigational product dosing.
Participants who have a fever at time of investigational product dosing can be enrolled as long as the fever is low-grade (oral temperature less than (<) 37.7 degree Celsius (°C) /100.9 degrees Fahrenheit (ºF)) and, regardless of temperature, the fever has not lasted for more than (>) 48 hours as determined by the Investigator.
Participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Participants with any condition or history felt by the Investigator to place the child at risk.
Participants with history of angioedema and bronchospastic reactivity to aspirin or other non-steroidal anti-inflammatory drug (NSAID).
Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: Ibuprofen, or any other NSAID such as aspirin or naproxen, acetaminophen (paracetamol), or topical anesthetics (e.g., EMLA® cream).
Single group
Test Product
DrugLiquid suspension FDC IBU 62.5 mg / APAP 125 mg
Area Under the Plasma Concentration Versus (Vs.) Time Curve Calculated from Time 0 to the Last Measurable Sampling Time Point (AUC0-t) for Ibuprofen and Acetaminophen
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).
Area Under the Plasma Concentration Vs. Time Curve Calculated from Time 0 To Infinity (AUC0-inf) for Ibuprofen and Acetaminophen
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.
Peak or Maximum Observed Plasma Concentration (Cmax) for Ibuprofen and Acetaminophen
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.
Time to Reach Maximum Plasma Concentration (Tmax) for Ibuprofen and Acetaminophen
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.
