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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Teva Pharmaceuticals USA
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Polyestradiol phosphate

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.