Randomized, Crossover and Single-Dose Bioequivalence Study of Two Oral Desogestrel Formulations (Film-Coated Tablets of 75 µg) in Healthy Female Volunteers

• DOI: 10.3797/scipharm.1111-18
• Publication Date: 2012-04-02T17:29:08Z
• Authors: María Ángeles Pena
• Keywords: Bioequivalence; Desogestrel; Tolerability; Crossover study

Despite the increase in substitution of branded medicinal product with generic drugs, this is a controversial issue for some pharmacological groups (such as contraceptives).The aim present clinical trial was to assess bioequivalence and tolerability two oral formulations desogestrel.Thirty-three healthy female volunteers participated randomized two-way crossover study. During separate experimental periods, at least four weeks washout period, women received single dose 75 μg desogestrel from each (test formulation reference formulation). Desogestrel bioavailability determined by measurement 3-ketodesogestrel plasma concentration.Pharmacokinetic parameters were comparable 90% CI ratio Cmax (96.14–114.53%) AUC0–t (105.73–123.83%) values test fell within established regulatory interval (80–125%). Both also terms tolerability.From results study it can be concluded that (desogestrel μg, Cyndea PHARMA S.L.) bioequivalent (Cerazet® Organon Española S.A.).