A pharmacokinetic profiling study after single-tablet regimen of camylofin 50 mg and paracetamol 325 mg in healthy participants

Objectives: Camylofin is widely used in combination with non-steroidal anti-inflammatory drugs such as paracetamol and nimesulide, but there is a dearth of information about its pharmacokinetic properties. Here, we assessed the pharmacokinetic parameters of a fixed-dose combination of camylofin 50 mg and paracetamol 325 mg in healthy volunteers. Materials and Methods: Eligible participants were admitted for fasting and fed visits, where 5 mL of blood was collected at multiple time points over 8 h. Serum concentrations of both drugs were analysed using the method of liquid chromatography/tandem mass spectrometry. Key primary pharmacokinetic outcome measures that were analysed were maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC0-8hrs), elimination constant (Kel), volume of distribution (Vd), clearance (CL) and half-life (t1/2). Results: Pharmacokinetic analysis was performed for 12 enrolled participants in both fasting and fed states. Mean (standard deviation [SD]) t1/2 (h) of camylofin was 1.16 (0.53) and 1.68 (0.55) in the states of fasting and fed, respectively, of paracetamol was 2.3 (0.35) in both states. Mean (SD) absolute Vd (L) was 32123.3 (15630.9) and 32928 (14734.4) for camylofin and 93.27 (31.73) and 87.61 (15.48) for paracetamol, respectively. Mean (SD) CL (L/hr) in the two states was 22958.33 (14314) and 14213 (7433.46) for camylofin and 28.07 (7.3) and 26.68 (4.86) for paracetamol, respectively. Mean (SD) Kel was 0.69 (0.26) and 0.46 (0.17) for camylofin, 0.31 (0.04), and 0.30 (0.04) for paracetamol, respectively. Conclusion: In the absence of other studies on pharmacokinetic parameters, findings from the current study may be considered as a reference for future research and development on camylofin.