Journal of Bioequivalence & Bioavailability

Maria Elena Jaramillo

Publications

• Research Article
  Bioavailability Comparison of Two Zopiclone Formulations in Healthy Colombian Volunteers
  Author(s): Adriana Ruiz, Fanny Cuesta, Paula Castaño, Omar Correa, Karina Gómez and Maria Elena JaramilloAdriana Ruiz, Fanny Cuesta, Paula Castaño, Omar Correa, Karina Gómez and Maria Elena Jaramillo
  
  Zopiclone is a hypnotic short-acting agent used in the treatment of primary insomnia. The aim of this study was to compare the Bioequivalence of two formulations of Zopiclone available in the Colombian market: Zopiclone 7.5 mg commercialized as Zopiclone MK® and Zopicloteg TG® (Test product) manufactured by Tecnoquímicas S.A (Cali, Col.) and Imovane® (Reference product) from Sanofi-Aventis Farmacéutica Ltda (Brasil). With this purpose, a single dose, randomized, crossover, with two periods, two sequences and a washout period of one week study was developed. Blood samples were drawn from 0 to 24 hours following the drug administration. Zopiclone plasma levels were determined by HPLC method, validated under the FDA parameters. The 90% confidence intervals for the ratios of the ln AUC0-∞ and ln Cmax means between the Test and Reference product were constru.. View More»
  DOI: 10.4172/jbb.1000246

  Abstract PDF