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

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

Overview[ - collapse ][ - ]

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	Healthy
Intervention	Drug: Norethindrone/Ethinyl Estradiol Drug: FEMCON® Fe
Phase	Phase 1
Sponsor	Teva Pharmaceuticals USA
Responsible Party	Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier	NCT01344369
First Received	April 27, 2011
Last Updated	May 4, 2011
Last verified	May 2011

Tracking Information[ + expand ][ + ]

First Received Date	April 27, 2011
Last Updated Date	May 4, 2011
Start Date	August 2008
Estimated Primary Completion Date	September 2008
Current 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).
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Condition	Healthy
Intervention	Drug: Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets Other Names: Zeosa®Drug: FEMCON® Fe 0.4 mg/0.035 mg Chewable Tablets Other Names: Ovcon® 35 Fe norethindrone/ethinyl estradiol (generic name)
Study Arm (s)	Experimental: Investigational Test Product Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) Active Comparator: Reference Listed Drug FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	36
Estimated Completion Date	September 2008
Estimated Primary Completion Date	September 2008
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.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01344369
Other Study ID Numbers	10816221
Has Data Monitoring Committee	No
Information Provided By	Teva Pharmaceuticals USA
Study Sponsor	Teva Pharmaceuticals USA
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	May 2011

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