Conditions: Bioequivalence
Keywords: Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: yes

Brief summary:
This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 \* 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.

Detailed description:

Arms:
arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/35 mcg Chewable Tablets (Teva) arm 2: Ovcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott)

Interventions: intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: Ovcon® 35 Fe
Intervention descriptions: intervention 1: 0.4 mg/35 mcg Chewable Tablets intervention 2: 0.4 mg/35 mcg Chewable Tablets

Protocol document: