Trial Outcomes & Findings for Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions (NCT NCT01340625)
NCT ID: NCT01340625
Last Updated: 2011-05-25
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
2011-05-25
Participant Flow
Participant milestones
| Measure |
Norethindrone/Ethinyl Estradiol (Test) First
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
|
Ovcon® 35 Fe (Reference) First
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
18
|
18
|
|
First Intervention
COMPLETED
|
17
|
18
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout Period of 28 Days
STARTED
|
17
|
18
|
|
Washout Period of 28 Days
COMPLETED
|
16
|
18
|
|
Washout Period of 28 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
16
|
18
|
|
Second Intervention
COMPLETED
|
16
|
18
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Norethindrone/Ethinyl Estradiol (Test) First
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
|
Ovcon® 35 Fe (Reference) First
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
|
Washout Period of 28 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Norethindrone/Ethinyl Estradiol (Test) First
n=18 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
|
Ovcon® 35 Fe (Reference) First
n=18 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg 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
American Indian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 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=34 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
|
Ovcon® 35 Fe (Reference)
n=34 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Norethindrone
|
10.94 ng/mL
Standard Deviation 5.22
|
10.00 ng/mL
Standard Deviation 4.13
|
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=34 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
|
Ovcon® 35 Fe (Reference)
n=34 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Norethindrone
|
43.83 ng*h/mL
Standard Deviation 30.50
|
40.73 ng*h/mL
Standard Deviation 22.41
|
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=34 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
|
Ovcon® 35 Fe (Reference)
n=34 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Norethindrone
|
48.67 ng*h/mL
Standard Deviation 34.36
|
45.43 ng*h/mL
Standard Deviation 27.03
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: 34 out of 36 subjects completed the study. Subjects 13 \& 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol (Test)
n=32 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
|
Ovcon® 35 Fe (Reference)
n=32 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Ethinyl Estradiol
|
230.56 pg/mL
Standard Deviation 74.02
|
237.00 pg/mL
Standard Deviation 62.90
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: 34 out of 36 subjects completed the study. Subjects 13 \& 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.
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=32 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
|
Ovcon® 35 Fe (Reference)
n=32 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Ethinyl Estradiol
|
1976.72 pg*h/mL
Standard Deviation 518.96
|
1989.82 pg*h/mL
Standard Deviation 475.30
|
PRIMARY outcome
Timeframe: Blood samples collected over a 60 hour period.Population: 34 out of 36 subjects completed the study. Subjects 13 \& 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.
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=32 Participants
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
|
Ovcon® 35 Fe (Reference)
n=32 Participants
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Ethinyl Estradiol
|
2129.43 pg*h/mL
Standard Deviation 560.04
|
2131.84 pg*h/mL
Standard Deviation 545.91
|
Adverse Events
Norethindrone/Ethinyl Estradiol (Test) First
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ovcon® 35 Fe (Reference) First
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Norethindrone/Ethinyl Estradiol (Test) First
n=36 participants at risk
0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
|
Ovcon® 35 Fe (Reference) First
n=36 participants at risk
0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
|
|---|---|---|
|
General disorders
Diarrhoea
|
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
Headache
|
25.0%
9/36 • Number of events 11 • 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.
|
25.0%
9/36 • Number of events 11 • 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
|
22.2%
8/36 • Number of events 9 • 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 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
Pallor
|
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.
|
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
Syncope
|
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.
|
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.
|
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