A clinical trial was carried out to determine the absorption rate and bioavailability of paracetamol in Oral Solution. A selection was made of 18 healthy volunteers of both sexes who signed an informed consent form and were examined in accordance with the generally accepted procedures for this type of studies. The subjects received a single dose of 650 mg of paracetamol in the form of 10 ml of solution (of the preparation Gelocatil Oral Solution from Laboratorios Gelos S.L.). Determinations were made of the plasma concentrations of paracetamol immediately before administration of the drug (0 h) and at 10 min, 20 min, 30 min, 45 min, 1 h, 1,5 h, 2 h, 3 h, 4 h, 6 h, 8 h and 12 h after administration. Calculations were made of the pharmacokinetic parameters derived from these extractions. All the subjects presented plasma concentrations of paracetamol above the quantification limit at 10 min after administration and 7 of them (39%) had already reached the maximum concentration at 10 minutes. The mean tmax in the 18 volunteers was 20 minutes and the maximum mean concentration was 14.45 mg.l-1. The preparation showed good tolerability and no adverse events were recorded in relation to the drug administered. It therefore seems that the results of this study enable us to state that paracetamol in Oral Solution has good bioavailability, a rapid absorption rate, and reaches high concentrations of paracetamol just a short time after administration.
|Publication status||Published - 1 Dec 2002|
- Healthy volunteers