Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions

Overview

The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions in healthy, non-tobacco using, adult female subjects.

Full Title of Study: “A Study to Evaluate the Relative Bioavailability of Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva Pharmaceuticals, USA) Compared to FEMCON® Fe (Norethindrone/Ethinyl Estradiol) 0.4 mg/0.035 mg Chewable Tablets (Warner Chilcott) in Healthy Female Volunteers Under Non-Fasted Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2008

Interventions

  • Drug: Norethindrone/Ethinyl Estradiol
    • 0.4 mg/0.035 mg Chewable Tablets
  • Drug: FEMCON® Fe
    • 0.4 mg/0.035 mg Chewable Tablets

Arms, Groups and Cohorts

  • Experimental: Investigational Test Product
    • Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva)
  • Active Comparator: Reference Listed Drug
    • FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

Clinical Trial Outcome Measures

Primary Measures

  • Cmax of Norethindrone
    • Time Frame: Blood samples collected over a 60 hour period.
    • Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
  • AUC0-t of Norethindrone
    • Time Frame: Blood samples collected over a 60 hour period.
    • Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
  • AUC0-inf of Norethindrone
    • Time Frame: Blood samples collected over a 60 hour period.
    • Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
  • Cmax of Ethinyl Estradiol
    • Time Frame: Blood samples collected over a 60 hour period.
    • Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
  • AUC0-t of Ethinyl Estradiol
    • Time Frame: Blood samples collected over a 60 hour period.
    • Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
  • AUC0-inf of Ethinyl Estradiol
    • Time Frame: Blood samples collected over a 60 hour period.
    • Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).

Participating in This Clinical Trial

Inclusion Criteria

  • Females, 18-45 years of age inclusive with Body Mass Index within 18-30 kg/m2 inclusive, as described in Novum Standard Operating Procedures. Female subjects must either abstain from sexual intercourse or use a reliable non-hormonal method of contraception (e.g. condom with spermicide, diaphragm, non-hormonal IUD) from at least 14 days prior to the first study dosing, throughout the study, and until 14 days after the last dose. – Normal menstrual cycle. – Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. – Signed and dated informed consent form, which meets all criteria of current FDA regulations. Exclusion Criteria:
  • Post menopausal or have irregular menstrual cycle. – Pregnant, lactating, or likely to become pregnant during the study. – History of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study. – Significant history or current evidence of chronic infectious disease, system disorder, or organ dysfunction. – Presence of gastrointestinal disease or history of malabsorption within the last year. – History of psychiatric disorders occurring within the last two years that required hospitalization or medication. – Presence of a medical condition requiring regular treatment with prescription drugs. – Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. – Participation in any clinical trial within 30 days prior to dosing. – Drug or alcohol addiction requiring treatment in the past 12 months. – Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing. – Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody. – Positive test results for drugs of abuse at screening. – Positive serum pregnancy test. – Subjects who have ever had progestational hormone implants. – Subjects who have had progestational hormone depot injections within 12 months proceeding dosing. – Subjects who are using or have used within the 3 months preceding dosing any vaginally administered estrogen or progestin-containing products. – Any personal or strong family history of estrogen- or progestogen-dependent tumors. – History of clinically significant fibrocystic breast disease. – Subjects with a history of thromboembolic disorders, myocardial infarction, or stroke. – Use of norethindrone or ethinyl estrodiol-containing oral contraceptives within 30 days of initial dosing. – Hysterectomy or oophorectomy (unilateral or bilateral) – User of tobacco or nicotine containing products within 30 days of the start of the study.
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: 45 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Teva Pharmaceuticals USA
    • Provider of Information About this Clinical Study
      • Associate Director, Biopharmaceutics, Teva Pharmaceuticals, USA

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