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NCT01344369 · ClinicalTrials.gov registry record · Phase 1
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01344369: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01344369 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01344369, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Interventions
- DRUG Norethindrone/Ethinyl Estradiol
- DRUG FEMCON® Fe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-08 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
What the finished NCT01344369 record still lists
NCT01344369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Norethindrone/Ethinyl Estradiol is the first listed.
NCT01344369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01344369 about?
NCT01344369 is a clinical study titled "Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions". 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...
What is the current status of trial NCT01344369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2008-08. Estimated completion is 2008-09.
What interventions are being tested in trial NCT01344369?
The interventions under investigation include: Norethindrone/Ethinyl Estradiol (DRUG), FEMCON® Fe (DRUG).
Who is sponsoring clinical trial NCT01344369?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01344369's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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