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

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Norethindrone/Ethinyl Estradiol (Drug); FEMCON® Fe (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA


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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax of Norethindrone

AUC0-t of Norethindrone

AUC0-inf of Norethindrone

Cmax of Ethinyl Estradiol

AUC0-t of Ethinyl Estradiol

AUC0-inf of Ethinyl Estradiol


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


- 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


- 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


Locations and Contacts

Novum Pharmaceutical Research Services, Houston, Texas 77042-4712, United States
Additional Information

Starting date: August 2008
Last updated: May 4, 2011

Page last updated: August 23, 2015

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