Trial Outcomes & Findings for Anastrozole 1 mg Tablets Under Fasting Conditions (NCT NCT01182181)
NCT ID: NCT01182181
Last Updated: 2010-11-15
Results Overview
Bioequivalence based on Anastrozole Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Blood samples collected over a 72 hour period.
Results posted on
2010-11-15
Participant Flow
Participant milestones
| Measure |
Anastrazole (Test) First
1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
|
Arimidex® (Reference) First
1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
10
|
11
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout of 21 Days
STARTED
|
10
|
11
|
|
Washout of 21 Days
COMPLETED
|
10
|
10
|
|
Washout of 21 Days
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Anastrazole (Test) First
1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
|
Arimidex® (Reference) First
1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
|
Washout of 21 Days
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Anastrozole 1 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Arimidex® (Reference) First
n=11 Participants
1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
|
Total
n=22 Participants
Total of all reporting groups
|
Anastrazole (Test) First
n=11 Participants
1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Anastrozole Cmax.
Outcome measures
| Measure |
Anastrazole (Test)
n=20 Participants
1 mg Anastrozole Tablets test product dosed in either period.
|
Arimidex® (Reference)
n=20 Participants
1 mg Arimidex® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
|
17.1 ng/mL
Standard Deviation 3.3
|
17.8 ng/mL
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Anastrozole AUC0-t.
Outcome measures
| Measure |
Anastrazole (Test)
n=20 Participants
1 mg Anastrozole Tablets test product dosed in either period.
|
Arimidex® (Reference)
n=20 Participants
1 mg Arimidex® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
503 ng*h/mL
Standard Deviation 110
|
519 ng*h/mL
Standard Deviation 94
|
Adverse Events
Anastrazole (Test)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arimidex® (Reference)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anastrazole (Test)
n=22 participants at risk
1 mg Anastrozole Tablets test product dosed in either period.
|
Arimidex® (Reference)
n=22 participants at risk
1 mg Arimidex® Tablets reference product dosed in either period.
|
|---|---|---|
|
General disorders
Hematuria
|
9.1%
2/22 • 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.
|
4.5%
1/22 • 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
Abnormal Urine
|
9.1%
2/22 • 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.
|
4.5%
1/22 • 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
|
0.00%
0/22 • 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.
|
9.1%
2/22 • 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.
|
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