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NCT01182207 · ClinicalTrials.gov registry record · Phase 1

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions

A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target
1
Study location

NCT01182207: Completed Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.

NCT01182207 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 33 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01182207, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target
1
Study location

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 tablets) in healthy, adult subjects under non-fasting conditions.

Primary Outcome

Bioequivalence based on Drospirenone Cmax.

Conditions Studied

Healthy

Interventions

  • DRUG Drospirenone/Ethinyl Estradiol (Gianvi®)
  • DRUG YAZ®

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2006-07
Est. Completion 2006-08
Phase Phase 1
Teva Pharmaceuticals U

19 total trials

What the finished NCT01182207 record still lists

NCT01182207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Drospirenone/Ethinyl Estradiol (Gianvi®) is the first listed.

NCT01182207 reports a single indexed study location in North Dakota.

Frequently Asked Questions

What is clinical trial NCT01182207 about?

NCT01182207 is a clinical study titled "Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-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 tablets) in healthy, adult subjects under non-fasting con...

What is the current status of trial NCT01182207?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2006-07. Estimated completion is 2006-08.

What conditions does trial NCT01182207 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01182207?

The interventions under investigation include: Drospirenone/Ethinyl Estradiol (Gianvi®) (DRUG), YAZ® (DRUG).

Who is sponsoring clinical trial NCT01182207?

This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01182207 being conducted?

This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01182207's enrollment target sits among peer trials

33 641st of 1090 higher than 445 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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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Related registry views

Source: ClinicalTrials.gov NCT01182207, the US trial registry maintained by the National Library of Medicine. NCT01182207 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.