Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions

NCT01340625 | Completed Phase 1 Results

• 1 other identifier: R06-1188
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 \* 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.

Conditions

Bioequivalence

Keywords

Healthy Subjects

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/35 mcg Chewable Tablets (Teva)

Drug: Norethindrone/Ethinyl Estradiol

Reference Listed Drug

ACTIVE COMPARATOR

Ovcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott)

Drug: Ovcon® 35 Fe

Interventions

Norethindrone/Ethinyl Estradiol DRUG

0.4 mg/35 mcg Chewable Tablets

Also known as: Zeosa®

Investigational Test Product

Ovcon® 35 Fe DRUG

0.4 mg/35 mcg Chewable Tablets

Also known as: Femcon® Fe, Norethindrone/Ethinyl Estradiol (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers who have been informed of the nature of the study and agree to read, review, and sign the informed consent document prior to Period I dosing.
• Volunteers who have completed the screening process within 28 days prior to Period I dosing.
• Volunteers who are healthy adult women 18-35 years of age, inclusive, at the time of dosing.
• Volunteers who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weight at least 110 lbs.
• Volunteers who are healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments, and by general observations. The physical examination will also include a gynecological exam. If the subject has completed an acceptable Papanicolaou smear and gynecological exam in the previous 12 months and documentation of acceptable results are provided, both will be deferred. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
• Volunteers must practice an acceptable non-hormonal birth control method as judged by the investigator(s) at least 14 days prior to Period I dosing, throughout the study, and until 14 days after second period dosing.

You may not qualify if:

• Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
• Volunteers who report taking any oral contraceptives including estrogen and progestin combined pills and progestin only pills or patch within 28 days prior to Period I dosing, using injectable contraceptives within 6 months of first period dosing.
• Volunteers who have ever had progestational hormone implants.
• Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems or psychiatric disease as determined by the clinical investigator(s).
• Volunteers who report any presence or history of migraines or severe headaches.
• Volunteers who have systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 45 or over 90 mmHg will be excluded from the study.
• Volunteers who have a history of thrombotic disorders or have ever had cerebrovascular accident or transient ischemic attacks.
• Volunteers with a history of breast cancer or undiagnosed breast nodules, active malignancies or undiagnosed vaginal bleeding.
• Volunteers having other conditions that may be aggravated by fluid retention (as determined by principal investigator).
• Volunteers who have a history of jaundice with previous use of oral contraceptives or any other kinds of hormonal contraceptives.
• Volunteers whose clinical laboratory test values fall outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
• Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• Volunteers who report a history of allergic response(s) to norethindrone/ethinyl estradiol or progestin/estrogens or related drugs.
• Volunteers who report the use of any systemic prescription medication in the 14 days prior to Period I dosing (with the exception of hormonal contraceptives).
• Volunteers with a history of clinically significant allergies including drug allergies.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, 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 20, 2011
• First Posted: April 22, 2011
• Study Start: December 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: May 25, 2011
• Results First Posted: May 25, 2011

Record last verified: 2011-04

Locations

US (1)