Clinical trial NCT01344369: Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Bioequivalence
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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.

Primary outcomes:
measure: Cmax of Norethindrone
timeFrame: Blood samples collected over a 60 hour period.
measure: AUC0-t of Norethindrone
timeFrame: Blood samples collected over a 60 hour period.
measure: AUC0-inf of Norethindrone
timeFrame: Blood samples collected over a 60 hour period.
measure: Cmax of Ethinyl Estradiol
timeFrame: Blood samples collected over a 60 hour period.
measure: AUC0-t of Ethinyl Estradiol
timeFrame: Blood samples collected over a 60 hour period.
measure: AUC0-inf of Ethinyl Estradiol
timeFrame: Blood samples collected over a 60 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
References: