Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
Condition: Healthy
Intervention: Norethindrone/Ethinyl Estradiol; FEMCON® Fe
Intervention description: 0.4 mg/0.035 mg Chewable Tablets; 0.4 mg/0.035 mg Chewable Tablets
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Subjects; Bioequivalence

Summary:

      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.
    

Eligibility criteria:

        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.