Trial Outcomes & Findings for Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions (NCT NCT01344369)
NCT ID: NCT01344369
Last Updated: 2011-05-30
Results Overview
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Blood samples collected over a 60 hour period.
Results posted on
2011-05-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention
STARTED
|
18
|
18
|
|
First Intervention
COMPLETED
|
18
|
18
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 28 Days
STARTED
|
18
|
18
|
|
Washout of 28 Days
COMPLETED
|
17
|
17
|
|
Washout of 28 Days
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
17
|
17
|
|
Second Intervention
COMPLETED
|
17
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Washout of 28 Days
Withdrawal by Subject
|
1
|
0
|
|
Washout of 28 Days
Physician Decision
|
0
|
1
|
|
Second Intervention
Emesis within 2 x Tmax
|
0
|
1
|
Baseline Characteristics
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
Baseline characteristics by cohort
| Measure |
Norethindrone/Ethinyl Estradiol (Test) First
n=18 Participants
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.
|
FEMCON® Fe (Reference) First
n=18 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=33 Participants
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=33 Participants
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Norethindrone
|
4.3306 ng/mL
Standard Deviation 1.7393
|
4.2282 ng/mL
Standard Deviation 1.6696
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=33 Participants
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=33 Participants
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Norethindrone
|
37.8065 ng*h/mL
Standard Deviation 16.1921
|
37.3991 ng*h/mL
Standard Deviation 15.3939
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=33 Participants
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=33 Participants
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Norethindrone
|
43.9982 ng*h/mL
Standard Deviation 19.4559
|
43.8819 ng*h/mL
Standard Deviation 18.8478
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=33 Participants
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=33 Participants
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Ethinyl Estradiol
|
137.6758 pg/mL
Standard Deviation 33.6231
|
137.8485 pg/mL
Standard Deviation 37.6177
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=33 Participants
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=33 Participants
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Ethinyl Estradiol
|
1916.2311 pg*h/mL
Standard Deviation 433.4875
|
1987.6311 pg*h/mL
Standard Deviation 478.7842
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=33 Participants
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=33 Participants
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Ethinyl Estradiol
|
2072.5423 pg*h/mL
Standard Deviation 483.0176
|
2152.3775 pg*h/mL
Standard Deviation 517.5977
|
Adverse Events
Norethindrone/Ethinyl Estradiol (Test)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
FEMCON® Fe (Reference)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=36 participants at risk
0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
|
FEMCON® Fe (Reference)
n=36 participants at risk
0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
|
|---|---|---|
|
General disorders
Abdominal Cramping
|
11.1%
4/36 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
0.00%
0/36 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Sinus Congestion
|
0.00%
0/36 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.6%
2/36 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Decreased Blood Pressure
|
5.6%
2/36 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.6%
2/36 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Vomiting
|
13.9%
5/36 • Number of events 5 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
8.3%
3/36 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Nausea
|
16.7%
6/36 • Number of events 6 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
8.3%
3/36 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Headache
|
13.9%
5/36 • Number of events 5 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Increased Temperature
|
0.00%
0/36 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.6%
2/36 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Increased Blood Pressure
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.6%
2/36 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
Additional Information
Associate Director, Biopharmaceutics
Teva Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER