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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01344369
The ClinicalTrials.gov registry entry for NCT01344369 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals USA, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Norethindrone/Ethinyl Estradiol is the first listed.
NCT01344369 reports 0 study locations.
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.
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