CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Norethindrone/Ethinyl Estradiol +1 moredrug
Likely dose
Norethindrone/Ethinyl Estradiol 0.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01344369
NCT01344369Phase 1Completed
CompareCT.gov

A Study to Evaluate the Relative Bioavailability of Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva Pharmaceuticals, USA) Compared to FEMCON® Fe (Norethindrone/Ethinyl Estradiol) 0.4 mg/0.035 mg Chewable Tablets (Warner Chilcott) in Healthy Female Volunteers Under Non-Fasted Conditions

Teva Pharmaceuticals USA·interventional·Posted Apr 29, 2011·Updated May 30, 2011

In Brief

A Phase 1 clinical trial evaluating Norethindrone/Ethinyl Estradiol and FEMCON® Fe for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 29, 2011
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.2 years ago

Interventions

Norethindrone/Ethinyl Estradioldrug

0.4 mg/0.035 mg Chewable Tablets

FEMCON® Fedrug

0.4 mg/0.035 mg Chewable Tablets