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NCT01340625 · ClinicalTrials.gov registry record · Phase 1
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
A Phase 1 study of Bioequivalence, sponsored by Teva Pharmaceuticals U.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01340625: Completed Phase 1 study of Bioequivalence, sponsored by Teva Pharmaceuticals U.
NCT01340625 is a Phase 1 study of Bioequivalence that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 36 participants, below the 60-participant average among 3 other Bioequivalence trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01340625, a Phase 1 study of Bioequivalence, has completed, sponsored by Teva Pharmaceuticals U.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Conditions Studied
Interventions
- DRUG Norethindrone/Ethinyl Estradiol
- DRUG Ovcon® 35 Fe
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-01 |
| Phase | Phase 1 |
What the finished NCT01340625 record still lists
NCT01340625 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 3 other Bioequivalence trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Bioequivalence appearing as the primary indexed condition, and to 2 interventions - of which Norethindrone/Ethinyl Estradiol is the first listed.
NCT01340625 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT01340625 about?
NCT01340625 is a clinical study titled "Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions". 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 sing...
What is the current status of trial NCT01340625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2006-12. Estimated completion is 2007-01.
What conditions does trial NCT01340625 study?
This clinical trial studies the following conditions: Bioequivalence.
What interventions are being tested in trial NCT01340625?
The interventions under investigation include: Norethindrone/Ethinyl Estradiol (DRUG), Ovcon® 35 Fe (DRUG).
Who is sponsoring clinical trial NCT01340625?
This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01340625 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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