Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Ta... | NCT01344369

NCT01344369

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Norethindrone/Ethinyl Estradiol	Drug	0.4 mg/0.035 mg Chewable Tablets	Investigational Test Product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Novum Pharmaceutical Research Services		Houston	Texas	77042-4712	United States

ID	Title	Description
FG000	Norethindrone/Ethinyl Estradiol (Test) First	0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
FG001	FEMCON® Fe (Reference) First	0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Norethindrone/Ethinyl Estradiol (Test) First	0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
BG001	FEMCON® Fe (Reference) First

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cmax of Norethindrone

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

All participants that completed the study had their samples analyzed.

Posted

Mean

Standard Deviation

ng/mL

Blood samples collected over a 60 hour period.

ID	Title	Description
OG000	Norethindrone/Ethinyl Estradiol (Test)	0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
OG001	FEMCON® Fe (Reference)	0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Norethindrone/Ethinyl Estradiol (Test)	0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.

ID	Term
C484525	ovcon 35
D009640	Norethindrone
D004997	Ethinyl Estradiol

ID	Term
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473