Resumen

PARASCA, Vasile  y  STARIS, Tamara. Bioequivalence of single dose, of two tablets of 2 mg chlormadinone acetate + 0.03 mg ethinyl estradiol León Farma Laboratories (Test) and the Belara® Grünental Laboratories (Reference). AVFT [online]. 2014, vol.33, n.2, pp.60-63. ISSN 0798-0264.

Objective: The purpose of the study was to assess the bioequivalence of chlormadinone acetate 2 mg + ethinyl estradiol 0,03 mg León Farma laboratories following administration of two tablets of 2 mg + 0.03 mg as a single oral dose two tablets of the product under test to reach levels detectable ethinyl estradiol compared with an equal dose of the reference product, the dose being administered in all cases to healthy volunteers under fasting conditions. Methods: Bioequivalence study of two periods, two sequences, exchange, and random blocks. The volunteers were retained in the hospital for 24 hours after drug administration. Then they continued the study attending the center after the programmed time interval for making the last samples. The drug administration was limited to a single oral dose of two tablets chlormadinone 2 mg + 0,03 mg ethinylestradiol blood samples were collected before drug administration (0.0) and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, 96.0, 120, 144.0 and 168.0 hours after dosing in each case. Elimination Period: 30 days. Analytical Method: HPLC-MS/MS. Relevant pharmacokinetic parameters: AUC_{0 - t}, Cmax, AUC_0-∞, Tmax, AUC_%-extra, t1/2, MRT, Kel. Results: Mean and confidence intervals for Cmax and AUC_{0- 24} and AUC_0-∞ were maintained in the ranges accepted for demonstrating bioequivalence. Conclusions: Both products are bioequivalent and therefore interchangeable.

Palabras clave : Chlormadinone; ethinylestradiol; bioequivalence; pharmacokinetics.