Resumen

MULLER, A et al. Ensayo clínico sobre la bioequivalencia clínica de una dosis de CLOPIDOGREL LETI CRAVID^® (CLOP-L) 75 mg. comprimidos frente a CLOPIDOGREL SANOFI PLAVIX^® (CLOP-S) 75 mg. tabletas administradas en una dosis diaria por 7 días en voluntarios sanos. AVFT [online]. 2010, vol.29, n.1, pp.15-19. ISSN 0798-0264.

Background The undergoing percutaneous coronary intervention procedures, as in patients with coronary disease should receive treatment indefinitely with acetylsalicylic acid (ASA) and Clopidogrel. Developing new products based on lower costs clopidogrel to help prevent premature discontinuation of antiplatelet therapy, among these products we have developed the brand Cravid^® of LETI S,A.V. Laboratories^® and this should compare their effectiveness and safety with the international standard Clopidogrel brand Plavix^® of Sanofi Aventis Laboratories. Methods: We conducted a study: a prospective, comparative, cross-randomized, in healthy volunteers. Each group received 1 tablet of Clopidogrel Leti, CLO-L or Clopidogrel Sanofi-LCLOP-S 75 mg. in a single dose daily for 7 days. Followed for 7 day-washout period before administration of second treatment. Platelet aggregation was measured at the beginning of each period and 7 days of treatment by agregometría optics. With a agregómetro Optical Model 490-2D. Results: In both groups there was a decrease in platelets add to the 7 days of treatment for more than 50% independent of the reagent ADP (Helena and cronolog) used to add (P <0.05). Conclusions: The mean and CI at 90%, obtained with two different trademarks of ADP were between 80 and 125%, which was concluded that both brands are bioequivalent and are therefore perfectly interchangeable.

Palabras clave : Clopidogrel; bioequivalence pharmacodynamic; platelet aggregation.