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COMPLETED Phase 1

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions

NCT01340625 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Norethindrone/Ethinyl Estradiol
  • DRUG Ovcon® 35 Fe

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. — Fargo

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-12
Est. Completion 2007-01
Phase Phase 1

Sponsor

Teva Pharmaceuticals U

19 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01340625

The ClinicalTrials.gov registry entry for NCT01340625 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals U, which has 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01340625 reports 1 study location spanning 1 distinct geographic area — top geographies include North Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01340625?

The interventions under investigation include: Norethindrone/Ethinyl Estradiol (DRUG), Ovcon® 35 Fe (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01340625?

This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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