Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®

Title A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets relative to Yaz® in healthy Thai female volunteers under fasting condition.

Objectives The primary objective is to compare the rate and extent of absorption of a generic formulation with that of a reference formulation when given as equal labeled dose. The secondary objective is to evaluate the safety after oral administration of both test and reference formulation in healthy Thai female volunteers.

Study Design Randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses.

Sample Size 32 Healthy Human Thai female subjects. Two extra subjects if available, may be checked-in on the day of check in of period-I to compensate for any dropout prior to dosing of period-I. These subjects will be dosed if there are dropouts prior to dosing in period-I. If there are no dropouts, these subjects will be checked-out without being dosed after completion of dosing in period-I.

Drug-Product Test-Product: Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Reference-product: Yaz® (Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets) Manufactured by: Bayer Weimar GmbH und Co. KG, Germany

Administration After an overnight fasting at clinical facility of at least 10 hours, each volunteer will receive a single dose of two tablets of Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets of either test or reference with 250 mL of drinking water. Each volunteer will be allowed to drink water as desire except 1 hour before and after drug administration. The formulation is given in a crossover fashion as per the randomization schedule. After the administration, the subject's oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacist.

Blood Schedule In each period, a total of 21 blood samples (approximately 10 mL each) will be collected pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours after study drug administration, respectively. The sample collection at 36.000, 48.000 and 72.000 hours after dosing will be on ambulatory basis (i.e. on separate visit.).