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.
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.