Bioequivalence study of two different coated tablet formulations of finasteride in healthy volunteers. 2005

Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
Medical Department, Grupo Tecnimede, Prior Velho (Portugal).

This study was conducted in order to assess the bioequivalence of two different coated tablet formulations containing 5 mg finasteride (CAS 98319-26-7). Twenty-six healthy volunteers were enrolled in an open, randomised, crossover single dose study with 2 periods x 2 sequences and a minimum washout period of 7 days. Plasma samples were obtained over 24 h (at baseline, +0.5 h, +1 h, +1.5 h, +2 h, +2.5 h, +3 h, 3.5 h, +4 h, +4.5 h, +5 h, +6 h, +8 h, +10 h, +12 h, +16 h and +24 h after administration). Finasteride levels were determined by high-pressure liquid chromatography with tandem mass detection, HPLC-MS/ MS, (LOQ 0.50 ng/mL). Pharmacokinetic parameters used for bioequivalence assessment (AUClast and Cmax were main evaluation criteria, however, AUCinf was also analysed) were determined from the finasteride concentration data using non-compartmental analysis. The 90 % confidence intervals (obtained by ANOVA) were 86.31-98.69 for Cmax, 95.40-104.88 for AUClast and 96.20-105.81 for AUCinf that is, they were all within the predefined ranges. It may be therefore concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D002138 Calibration Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output. Calibrations
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004791 Enzyme Inhibitors Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. Enzyme Inhibitor,Inhibitor, Enzyme,Inhibitors, Enzyme
D006207 Half-Life The time it takes for a substance (drug, radioactive nuclide, or other) to lose half of its pharmacologic, physiologic, or radiologic activity. Halflife,Half Life,Half-Lifes,Halflifes
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D013608 Tablets, Enteric-Coated Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed) Enteric-Coated Tablets,Tablets, Enteric Coated

Related Publications

Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
January 2011, Arzneimittel-Forschung,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
March 2014, Drug research,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
January 2008, Arzneimittel-Forschung,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
January 2009, Arzneimittel-Forschung,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
January 2011, Arzneimittel-Forschung,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
February 2008, Clinical and experimental hypertension (New York, N.Y. : 1993),
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
January 2011, Arzneimittel-Forschung,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
May 2012, International journal of clinical pharmacology and therapeutics,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
January 2011, Arzneimittel-Forschung,
Ana Almeida, and Susana Almeida, and Augusto Filipe, and Stéphanie Gagnon, and Aitor Mirapeix, and Benoît Girard, and Mario Tanguay
February 2009, International journal of clinical pharmacology and therapeutics,
Copied contents to your clipboard!