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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01344369
First received: April 27, 2011
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Norethindrone/Ethinyl Estradiol
Drug: FEMCON® Fe
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Norethindrone [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-t of Norethindrone [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  • AUC0-inf of Norethindrone [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).

  • Cmax of Ethinyl Estradiol [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-t of Ethinyl Estradiol [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  • AUC0-inf of Ethinyl Estradiol [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).


Enrollment: 36
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva)
Drug: Norethindrone/Ethinyl Estradiol
0.4 mg/0.035 mg Chewable Tablets
Other Name: Zeosa®
Active Comparator: Reference Listed Drug
FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)
Drug: FEMCON® Fe
0.4 mg/0.035 mg Chewable Tablets
Other Names:
  • Ovcon® 35 Fe
  • norethindrone/ethinyl estradiol (generic name)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344369

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042-4712
Sponsors and Collaborators
Teva Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01344369     History of Changes
Other Study ID Numbers: 10816221
Study First Received: April 27, 2011
Results First Received: May 4, 2011
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Healthy Subjects
Bioequivalence

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone acetate
Norinyl
Ethynylestradiol mixture with norethindrone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential

ClinicalTrials.gov processed this record on April 16, 2014