ClinicalTrials.gov
ClinicalTrials.gov Menu

Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01074463
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : April 30, 2010
Last Update Posted : April 30, 2010
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Intervention Drug: Pramipexole Dihydrochloride
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test (Pramipexole Dihydrochloride) First Reference (Mirapex®) First
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout of 7 Days
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Second Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Test (Pramipexole Dihydrochloride) First Reference (Mirapex®) First Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
5
  41.7%
7
  58.3%
12
  50.0%
Male
7
  58.3%
5
  41.7%
12
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Caucasian 10 12 22
Black 1 0 1
Native American 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 48 hour period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Test (Pramipexole Dihydrochloride) Reference (Mirapex®)
Hide Arm/Group Description:
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
0.25 mg Mirapex® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.61  (0.22) 0.54  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test (Pramipexole Dihydrochloride), Reference (Mirapex®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 109.18
Confidence Interval (2-Sided) 90%
99.25 to 120.12
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
2.Primary Outcome
Title AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Hide Description Bioequivalence based on AUC0-t.
Time Frame Blood samples collected over a 48 hour period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Test (Pramipexole Dihydrochloride) Reference (Mirapex®)
Hide Arm/Group Description:
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
0.25 mg Mirapex® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5.86  (1.18) 5.68  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test (Pramipexole Dihydrochloride), Reference (Mirapex®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 104.06
Confidence Interval (2-Sided) 90%
98.73 to 109.68
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
3.Primary Outcome
Title AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Hide Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 48 hour period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Test (Pramipexole Dihydrochloride) Reference (Mirapex®)
Hide Arm/Group Description:
0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
0.25 mg Mirapex® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
6.27  (1.21) 6.17  (1.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test (Pramipexole Dihydrochloride), Reference (Mirapex®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 102.34
Confidence Interval (2-Sided) 90%
97.78 to 107.11
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
Time Frame Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Adverse Event Reporting Description 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.
 
Arm/Group Title Test (Pramipexole Dihydrochloride) First Reference (Mirapex®) First
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Test (Pramipexole Dihydrochloride) First Reference (Mirapex®) First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Test (Pramipexole Dihydrochloride) First Reference (Mirapex®) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test (Pramipexole Dihydrochloride) First Reference (Mirapex®) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      4/24 (16.67%)    
General disorders     
Dizziness * 1  2/24 (8.33%)  2 0/24 (0.00%)  0
Headache * 1  0/24 (0.00%)  0 2/24 (8.33%)  2
Nausea * 1  0/24 (0.00%)  0 2/24 (8.33%)  2
Nervousness * 1  2/24 (8.33%)  2 0/24 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Name/Title: Associate Director, Biopharmaceutics
Organization: TEVA Pharmaceuticals, USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT01074463     History of Changes
Other Study ID Numbers: R04-1203
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: April 8, 2010
Results First Posted: April 30, 2010
Last Update Posted: April 30, 2010