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

Brief summary:
The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions in healthy, non-tobacco using, adult female subjects.

Detailed description:

Arms:
arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) arm 2: FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

Interventions: intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: FEMCON® Fe
Intervention descriptions: intervention 1: 0.4 mg/0.035 mg Chewable Tablets intervention 2: 0.4 mg/0.035 mg Chewable Tablets

Protocol document: