Overview

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Polyestradiol phosphate