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

NCT ID: NCT01344369

Last Updated: 2011-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-09-30

Brief 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.

Conditions

Healthy

Keywords

Healthy Subjects; Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Investigational Test Product

Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva)

Group Type: EXPERIMENTAL

Norethindrone/Ethinyl Estradiol

Intervention Type: DRUG

0.4 mg/0.035 mg Chewable Tablets

Reference Listed Drug

FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

Group Type: ACTIVE_COMPARATOR

FEMCON® Fe

Intervention Type: DRUG

0.4 mg/0.035 mg Chewable Tablets

Interventions

Norethindrone/Ethinyl Estradiol

0.4 mg/0.035 mg Chewable Tablets

Intervention Type: DRUG

FEMCON® Fe

0.4 mg/0.035 mg Chewable Tablets

Intervention Type: DRUG

Other Intervention Names

Zeosa®; Ovcon® 35 Fe; norethindrone/ethinyl estradiol (generic name)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Pharmaceuticals, USA

Locations

Novum Pharmaceutical Research Services

Houston, Texas, United States

Countries

United States

Other Identifiers

10816221

Identifier Type: -

Identifier Source: org_study_id