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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2006-06
Est. Completion 2006-08
Phase Phase 1

Sponsor

Teva Pharmaceuticals USA

83 total trials

What the Registry Record Tells You About NCT01182194

The ClinicalTrials.gov registry entry for NCT01182194 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 Drospirenone/Ethinyl Estradiol (Gianvi®) is the first listed.

NCT01182194 reports 0 study locations.

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.

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

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, the data changelog, or report a data error.