Abbott Laboratories Chile, Huechuraba, Chile
Research
An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Crossover, Single Dose, Oral Bioequivalence Study of Femelle 20 (Drospirenone 3 Mg and Ethinyl Estradiol 0.02 Mg) Coated Tablets of Abbott and Yaz® (Drospirenone 3 Mg And Ethinyl Estradiol 0.02 Mg) Coated Tablets of Bayer in Healthy, Adult, Human Female Subjects Under Fasting Condition
Author(s): Arjun Arumugam O*, Geethalakshmi G, Srinivas G, Kramm Karina, Sasso Jaime, Vergara Sebastian, Ghünter Erich, Salazar Boris, Sosa María del Milagro, Jimenez Julio, Gavino-Gutiérrez Arquímedes M, Lara Claudia and Higuera Maria Juliana
Yaz® Drospirenone and ethinyl estradiol is a Combined Oral Contraceptive (COC). Drospirenone is a spironolactone
analogue with anti-mineralocorticoid and anti-androgenic activity. The estrogen in Yaz® is ethinyl estradiol. COCs
lower the risk of becoming pregnant primarily by suppressing ovulation. Yaz® is also indicated for the treatment
of symptoms of Pre Menstrual Dysphoric Disorder (PMDD) in women who choose to use an oral contraceptive as
their method of contraception. The purpose of this study was to evaluate the bioequivalence between Femelle 20
(Drospirenone 3 mg and ethinyl estradiol 0.02 mg) coated tablets of Abbott versus Yaz® (Drospirenone 3 mg and
ethinyl estradiol 0.02 mg) coated tablets of Bayer under fasting condition in healthy non-pregnant female subjects.
An open label, balanced, randomize.. View more»