Trial Outcomes & Findings for Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions (NCT NCT01074463)
NCT ID: NCT01074463
Last Updated: 2010-04-30
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples collected over a 48 hour period.
Results posted on
2010-04-30
Participant Flow
Participant milestones
| Measure |
Test (Pramipexole Dihydrochloride) First
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
|
Reference (Mirapex®) First
0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
12
|
12
|
|
Washout of 7 Days
COMPLETED
|
12
|
12
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
12
|
|
Second Intervention
COMPLETED
|
12
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Test (Pramipexole Dihydrochloride) First
n=12 Participants
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
|
Reference (Mirapex®) First
n=12 Participants
0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
|
Total
n=24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Pramipexole Dihydrochloride)
n=24 Participants
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
|
Reference (Mirapex®)
n=24 Participants
0.25 mg Mirapex® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
0.61 ng/mL
Standard Deviation 0.22
|
0.54 ng/mL
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Pramipexole Dihydrochloride)
n=24 Participants
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
|
Reference (Mirapex®)
n=24 Participants
0.25 mg Mirapex® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
5.86 ng*h/mL
Standard Deviation 1.18
|
5.68 ng*h/mL
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Pramipexole Dihydrochloride)
n=24 Participants
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
|
Reference (Mirapex®)
n=24 Participants
0.25 mg Mirapex® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
6.27 ng*h/mL
Standard Deviation 1.21
|
6.17 ng*h/mL
Standard Deviation 1.40
|
Adverse Events
Test (Pramipexole Dihydrochloride) First
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Reference (Mirapex®) First
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 |
Test (Pramipexole Dihydrochloride) First
n=24 participants at risk
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
|
Reference (Mirapex®) First
n=24 participants at risk
0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
|
|---|---|---|
|
General disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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
Nervousness
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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