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/NCT01340625
NCT01340625Phase 1Completed
CompareCT.gov

A Relative Bioavailability Study of 0.4 mg/35 Mcg Norethindrone and Ethinyl Estradiol Chewable Tablets Under Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Apr 22, 2011·Updated May 25, 2011

In Brief

A Phase 1 clinical trial evaluating Norethindrone/Ethinyl Estradiol and Ovcon® 35 Fe for Bioequivalence. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2011
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.2 years ago

Interventions

Norethindrone/Ethinyl Estradioldrug

0.4 mg/35 mcg Chewable Tablets

Ovcon® 35 Fedrug

0.4 mg/35 mcg Chewable Tablets