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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 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.

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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.

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

Sponsor

Teva Pharmaceuticals U

19 total trials

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What the Registry Record Tells You About NCT01182207

The ClinicalTrials.gov registry entry for NCT01182207 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Teva Pharmaceuticals U, which has 19 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.