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

Phase 1 Completed 36 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2008-08
Primary completion: 2008-09
Completion: 2008-09

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 102.44 (90% CI 93.08 to 112.75) NCT01344369 ↗

registry Ratio of the T/R geometric mean x 100 100.58 (90% CI 96.66 to 104.66) NCT01344369 ↗

registry Ratio of the T/R geometric mean x 100 100.85 (90% CI 96.43 to 105.48) NCT01344369 ↗

registry Ratio of the T/R geometric mean x 100 100.59 (90% CI 93.69 to 108.00) NCT01344369 ↗

registry Ratio of the T/R geometric mean x 100 96.68 (90% CI 92.76 to 100.77) NCT01344369 ↗

registry Ratio of the T/R geometric mean x 100 96.44 (90% CI 92.22 to 100.84) NCT01344369 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norethindrone	Unknown	0.4 mg	—
Subject	ethinyl estradiol	Small molecule	0.035 mg	—

Indications

No indication recorded.