Resumen

HERNANDEZ H, José Manuel Eduardo et al. Evaluation of the comparative bioavailability of a test product containing Calcium Dobesilate 1000 mg, in extended release tablets of Leti Laboratories, S.A.V., once a day, against the reference product Doxium®, containing Calcium Dobesilate 500 mg, in immediate release capsules, of Leti Laboratories, S.A.V., given twice a day, for the same total dose of 1000 mg, in healthy volunteers. AVFT [online]. 2015, vol.34, n.1, pp.1-3. ISSN 0798-0264.

Objective: To compare the bioavailability of two formulations of Calcium Dobesilate after administration of one tablet of 1000 mg extended release (ER) once daily vs. Doxium^®, capsules of 500 mg immediate release in 2 doses (one c\12 hours). Methods: A crossover study, single-dose two treatments, two periods, two sequences, (2x2) with a washout period of 14 days, on 14 healthy volunteers was conducted in fasting conditions. Subjects were randomly assigned to each of the administration sequences. Volunteers received a single dose of 1000 mg Calcium Dobesilate tablets LP, or 1 capsule of 500 mg dose Doxium^® every 12 hours orally for 2 doses. Pharmacokinetic parameters were calculated (C_max, T_max, AUC_0-24 y AUC_0-inf) by the trapezoidal method; Software: Excel. The drug was quantified in plasma by liquid chromatography and UV / Vis detection. Comparing the mean and IC95% between 80% -125% for the ratio averages C_max, T_max, AUC_0-t y AUC_0-inf. Results: C_max 10.15±1.94 μ/mL vs. 8.96±1.88 μ/mL, T_max 4.79±0.2 h vs. 4.68±0.36 h, AUC_{0- 24} 92.84±15.96 μ/mL/h vs. 88.74±12.86 μ/mL/h and AUC_0-∞ 96.57±16.28 μ/mL/h vs. 93.35±15.28 μ/mL/h, respectively. IC95%: C_max 103.67%-107.93%, AUC_0-24 104.61%-108.75% y AUC_0-∞ 103.67%-107.93%. Conclusion: Calcium Dobesilate LP at a daily dose of 1000 mg showed to be absorbed at the same speed, as measured by C_max, and similar quantity, as measured by the AUC, so we expect similar therapeutic effects.

Palabras clave : Calcium Dobesilate; sustained release; tablets; capsules; bioavailability.