Expired Study
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Houston, Texas 77042


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.


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 of nicotine containing products within 30 days of the start of the study.


Study is Available At:


Original ID:

10816221


NCT ID:

NCT01344369


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Teva Pharmaceuticals USA


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Study Dates

Start Date:August 2008
Completion Date:September 2008
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 27, 2011
First Received Date:April 27, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cmax of Norethindrone
Time Frame:Blood samples collected over a 60 hour period.
Safety Issues:False
Description:Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Outcome Type:Primary Outcome
Measure:AUC0-t of Norethindrone
Time Frame:Blood samples collected over a 60 hour period.
Safety Issues:False
Description:Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome Type:Primary Outcome
Measure:AUC0-inf of Norethindrone
Time Frame:Blood samples collected over a 60 hour period.
Safety Issues:False
Description:Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome Type:Primary Outcome
Measure:Cmax of Ethinyl Estradiol
Time Frame:Blood samples collected over a 60 hour period.
Safety Issues:False
Description:Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
Outcome Type:Primary Outcome
Measure:AUC0-t of Ethinyl Estradiol
Time Frame:Blood samples collected over a 60 hour period.
Safety Issues:False
Description:Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome Type:Primary Outcome
Measure:AUC0-inf of Ethinyl Estradiol
Time Frame:Blood samples collected over a 60 hour period.
Safety Issues:False
Description:Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).

Study Interventions

Intervention Type:Drug
Name:Norethindrone/Ethinyl Estradiol
Description:0.4 mg/0.035 mg Chewable Tablets
Arm Name:Investigational Test Product
Other Name:Zeosa®
Intervention Type:Drug
Name:FEMCON® Fe
Description:0.4 mg/0.035 mg Chewable Tablets
Arm Name:Reference Listed Drug
Other Name:Ovcon® 35 Fe

Study Arms

Study Arm Type:Experimental
Arm Name:Investigational Test Product
Description:Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva)
Study Arm Type:Active Comparator
Arm Name:Reference Listed Drug
Description:FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Teva Pharmaceuticals USA

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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