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

NCT01344369 | Completed Phase 1 Results

• 1 other identifier: 10816221
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Cmax of Norethindrone

  Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).

  Blood samples collected over a 60 hour period.

• AUC0-t of Norethindrone

  Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  Blood samples collected over a 60 hour period.

• AUC0-inf of Norethindrone

  Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).

  Blood samples collected over a 60 hour period.

• Cmax of Ethinyl Estradiol

  Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).

  Blood samples collected over a 60 hour period.

• AUC0-t of Ethinyl Estradiol

  Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  Blood samples collected over a 60 hour period.

• AUC0-inf of Ethinyl Estradiol

  Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).

  Blood samples collected over a 60 hour period.

Study Arms (2)

Investigational Test Product

EXPERIMENTAL

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

Drug: Norethindrone/Ethinyl Estradiol

Reference Listed Drug

ACTIVE COMPARATOR

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

Drug: FEMCON® Fe

Interventions

Norethindrone/Ethinyl Estradiol DRUG

0.4 mg/0.035 mg Chewable Tablets

Also known as: Zeosa®

Investigational Test Product

FEMCON® Fe DRUG

0.4 mg/0.035 mg Chewable Tablets

Also known as: Ovcon® 35 Fe, norethindrone/ethinyl estradiol (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042-4712, United States

Location

MeSH Terms

Interventions

ovcon 35; Norethindrone; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: Teva Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 30, 2011
• Results First Posted: May 30, 2011

Record last verified: 2011-05

Locations

US (1)