Healthy volunteers, therapeutic indication not studied
Conditions
Brief summary
AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively
Detailed description
AUC0-tlast, Cmax and tmax for paracetamol and naproxen after administration of Test under fasted vs. Test under fed conditions, Tmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol after fasted administration of Reference 1, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for naproxen after fasted administration of Reference 2, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol and naproxen after administration of Test, under fasted and fed condition, Tolerability assessment based on AEs, vital signs and protocol-specified safety labs for Test and Reference treatments.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-tlast, Cmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-tlast, Cmax and tmax for paracetamol and naproxen after administration of Test under fasted vs. Test under fed conditions, Tmax for paracetamol and naproxen after fasted administration of Test vs. Reference 1 and Test vs. Reference 2, respectively, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol after fasted administration of Reference 1, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for naproxen after fasted administration of Reference 2, Pharmacokinetic parameters (tmax, AUC0-inf, %AUCex, λz, t1/2 ) for paracetamol and naproxen after administration of Test, under fasted and fed condition, Tolerability assessment based on AEs, vital signs and protocol-specified safety labs for Test and Reference treatments. | — |