Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
Condition: Bioequivalence
Intervention: Norethindrone/Ethinyl Estradiol; Ovcon® 35 Fe
Intervention description: 0.4 mg/35 mcg Chewable Tablets; 0.4 mg/35 mcg 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: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Subjects

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Volunteers who have been informed of the nature of the study and agree to read,
             review, and sign the informed consent document prior to Period I dosing.

          -  Volunteers who have completed the screening process within 28 days prior to Period I
             dosing.

          -  Volunteers who are healthy adult women 18-35 years of age, inclusive, at the time of
             dosing.

          -  Volunteers who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weight
             at least 110 lbs.

          -  Volunteers who are healthy as documented by the medical history, physical examination,
             vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments,
             and by general observations. The physical examination will also include a
             gynecological exam. If the subject has completed an acceptable Papanicolaou smear and
             gynecological exam in the previous 12 months and documentation of acceptable results
             are provided, both will be deferred. Any abnormalities/deviations from the normal
             range that might be considered clinically relevant by the study physician and
             investigator will be evaluated for individual cases, documented in study files, and
             agreed upon by both the study physician and investigator prior to enrolling the
             volunteer in this study and for continued enrollment.

          -  Volunteers must practice an acceptable non-hormonal birth control method as judged by
             the investigator(s) at least 14 days prior to Period I dosing, throughout the study,
             and until 14 days after second period dosing.

        Exclusion Criteria:

          -  Volunteers who report receiving any investigational drug within 30 days prior to
             Period I dosing.

          -  Volunteers who report taking any oral contraceptives including estrogen and progestin
             combined pills and progestin only pills or patch within 28 days prior to Period I
             dosing, using injectable contraceptives within 6 months of first period dosing.

          -  Volunteers who have ever had progestational hormone implants.

          -  Volunteers who report any presence or history of a clinically significant disorder
             involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic,
             hematologic, endocrine, or neurologic systems or psychiatric disease as determined by
             the clinical investigator(s).

          -  Volunteers who report any presence or history of migraines or severe headaches.

          -  Volunteers who have systolic blood pressure lower than 90 or over 140 mmHg, diastolic
             blood pressure lower than 45 or over 90 mmHg will be excluded from the study.

          -  Volunteers who have a history of thrombotic disorders or have ever had cerebrovascular
             accident or transient ischemic attacks.

          -  Volunteers with a history of breast cancer or undiagnosed breast nodules, active
             malignancies or undiagnosed vaginal bleeding.

          -  Volunteers having other conditions that may be aggravated by fluid retention (as
             determined by principal investigator).

          -  Volunteers who have a history of jaundice with previous use of oral contraceptives or
             any other kinds of hormonal contraceptives.

          -  Volunteers whose clinical laboratory test values fall outside the accepted reference
             range and when confirmed on re-examination is deemed to be clinically significant.

          -  Volunteers who demonstrate a reactive screen for hepatitis B surface antigen,
             hepatitis C antibody, or HIV antibody.

          -  Volunteers who report a history of allergic response(s) to norethindrone/ethinyl
             estradiol or progestin/estrogens or related drugs.

          -  Volunteers who report the use of any systemic prescription medication in the 14 days
             prior to Period I dosing (with the exception of hormonal contraceptives).

          -  Volunteers with a history of clinically significant allergies including drug
             allergies.

          -  Volunteers who report a clinically significant illness during the 4 weeks prior to
             Period I dosing (as determined by the clinical investigators).

          -  Volunteers who report a history of drug or alcohol addiction or abuse within the past
             year.

          -  Volunteers who demonstrate a positive drug abuse screen for this study prior to Period
             I dose administration.

          -  Volunteers who currently use or have used tobacco products within 30 days prior to
             Period I dosing.

          -  Volunteers who report donating greater that 150 mL of blood within 30 days prior to
             Period I dosing. All subjects will be advised not to donate blood for 4 weeks after
             completing the study.

          -  Volunteers who report donating plasma within 30 days prior to Period I dosing. All
             subjects will be advised not to donate plasma for 4 weeks after completing the study.

          -  Volunteers who demonstrate a positive pregnancy screen.

          -  Volunteers who are currently pregnant of breastfeeding.

          -  Volunteers who are using or have used within the 3 months preceding Period I dosing
             any vaginally administered estrogen or progestin-containing products.

          -  Any volunteer who engages in unprotected sexual intercourse during the time interval
             starting 14 days prior to first period dosing and until 14 days after the Period II
             dosing.

          -  Volunteers who have had a hysterectomy or oophorectomy (unilateral or bilateral).