[Relative bioavailability study of two oral formulations of mycophenolate mofetil in healthy volunteers]. / Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos.

BACKGROUND: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. AIM: To evaluate the relative bioavailability for an oralformulation of mycophenolate mofetil (MMF) (Linfonex™) compared to the reference formulation (Cellcept™) to determine the bioequivalence between both formulations. MATERIAL AND METHODS: A randomized, crossover, double-blind trial in 22 healthy male volunteers, who received a single oral dose of 1000 mg of Linfonex and Cellcept with a washout period of 10 days. Plasma levels of the drug were determined by high performance liquid chr ornatography. Plasma concentrations were plotted and maximum concentration, area under the plasma concentration versus time between 0 and 12 hours after administration and área under plasma concentration curve versus time after administration between 0 and infinity, were calculated for both products. RESULTS: The active compound, mycophenolic acid, was similarly absorbed in both formulations. No statistically significant differences were found in calculated pharmacokinetic parameters between both formulations. CONCLUSIONS: Linfonex™ 500 mg is bioequivalent to Cellcept™ 500 mg.

Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos / Relative bioavailability study of two oral formulations of mycophenolate mofetil in healthy volunteers

Background: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. Aim: To evaluate the relative bioavailability for an oralformulation of mycophenolate mofetil (MMF) (Linfonex™) compared to the reference formulation (Cellcept™) to determine the bioequivalence between both formulations. Material and Methods: A randomized, crossover, double-blind trial in 22 healthy male volunteers, who received a single oral dose of 1000 mg of Linfonex and Cellcept with a washout period of 10 days. Plasma levels of the drug were determined by high performance liquid chr ornatography. Plasma concentrations were plotted and maximum concentration, area under the plasma concentration versus time between 0 and 12 hours after administration and área under plasma concentration curve versus time after administration between 0 and infinity, were calculated for both products. Results: The active compound, mycophenolic acid, was similarly absorbed in both formulations. No statistically significant differences were found in calculated pharmacokinetic parameters between both formulations. Conclusions: Linfonex™ 500 mg is bioequivalent to Cellcept™ 500 mg.

Absorción y eliminación de amiodarona después de su administración oral e intravenosa en individuos sanos / Amiodarone absorption and disposal after intravenous administration in healthy individuals

We studied amiodarone absorption and disposal in 8 male helathy subjects aged 21ñ1 years old and weighting 69.8ñ7.1 kg. An intravenous dose of 5 mg/kg and an oral dose of 600 mg of amiodarone were administrated. Amiodarone concentrations were measured by HPLC and calculations were performed using a compartment model independent pharmacokinetic analysis program. After oral administration a Cmax of 1.17ñ0.3 mg/ml was achieved at 3.25ñ0.46 h (tmax). Absolute bioavailability ranged from 50.4 to 87.8 percent (68.6ñ12.6 percent). Compared to previous reports, the variability of this parameter is similar and the mean value is one of the highest informed. After intravenous administration, amiodarone had a half life of 7.35ñ0.96 h, a total body clearence of 4.25ñ0.73 ml/kg/min and a distribution volume of 2.99ñ0.71 l/kg. Except the later figure, which is in the inferior range, all other parameters are within previously reported values. It is concluded that amiodarone absorption and disposal values found in chilean subjects are similar to those reported abroad