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NCT01182194 · ClinicalTrials.gov registry record · Phase 1
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01182194: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01182194 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01182194, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult subjects administered under fasting conditions.
Primary Outcome
Bioequivalence based on Drospirenone Cmax.
Interventions
- DRUG Drospirenone/Ethinyl Estradiol (Gianvi®)
- DRUG YAZ®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-06 |
| Est. Completion | 2006-08 |
| Phase | Phase 1 |
What the finished NCT01182194 record still lists
NCT01182194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Drospirenone/Ethinyl Estradiol (Gianvi®) is the first listed.
NCT01182194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01182194 about?
NCT01182194 is a clinical study titled "Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.". This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult subjects administered under fas...
What is the current status of trial NCT01182194?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-06. Estimated completion is 2006-08.
What interventions are being tested in trial NCT01182194?
The interventions under investigation include: Drospirenone/Ethinyl Estradiol (Gianvi®) (DRUG), YAZ® (DRUG).
Who is sponsoring clinical trial NCT01182194?
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 NCT01182194's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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