Journal of Bioequivalence & Bioavailability

Abstract

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

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, randomized, two treatments, two sequences, two periods, crossover, single dose study with washout period of 14 days was carried out in 36 healthy non-pregnant female subjects in the age group of 22 to 42 years, who met the study eligibility criteria, participated in the study and all 36 subjects completed both the periods of the study. The pharmacokinetic samples collected from subjects who completed the study were analyzed to determine the plasma concentration of Drospirenone and ethinyl estradiol using a validated bio-analytical method. Ninety percent confidence interval of C_max and AUC_0-72 were 100.45%-119.63% and 98.04%-104.50%, respectively for Drospirenone and 90% confidence interval of C_max, AUC_0-t and AUC_0-∞ were 93.76%-102.39%, 102.42%-110.02% and 101.37%-108.84%, respectively for ethinyl estradiol, which were within the acceptable limits of 80.00% to 125.00%.

Published Date: 2023-10-05; Received Date: 2023-08-31