Trial Outcomes & Findings for Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers (NCT NCT01214109)
NCT ID: NCT01214109
Last Updated: 2014-06-27
Results Overview
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
27 days
Results posted on
2014-06-27
Participant Flow
24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented in the milestone are by overall treatment, A, B, C or D.
Participant milestones
| Measure |
0.375 mg q.d.Extended Release (ER)
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. Immediate Release (IR)
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
All Subjects
n=24 Participants
24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment.
|
|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 27 daysPopulation: PK population - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=23 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)
|
6.20 ng*h/mL
Geometric Coefficient of Variation 29.7
|
7.50 ng*h/mL
Geometric Coefficient of Variation 21.5
|
19.1 ng*h/mL
Geometric Coefficient of Variation 113
|
20.4 ng*h/mL
Geometric Coefficient of Variation 104
|
PRIMARY outcome
Timeframe: 27 daysPopulation: PK population excluding subjects with reported emesis - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER, excluding subjects with reported emesis
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)
|
6.64 ng*h/mL
Geometric Coefficient of Variation 19.6
|
7.44 ng*h/mL
Geometric Coefficient of Variation 22.6
|
24.8 ng*h/mL
Geometric Coefficient of Variation 34.6
|
27.4 ng*h/mL
Geometric Coefficient of Variation 40.4
|
PRIMARY outcome
Timeframe: 27 daysPopulation: PK population - Subjects with values for Cmax,ss
Cmax = maximum observed concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=24 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)
|
0.416 ng/mL
Geometric Coefficient of Variation 25.3
|
0.469 ng/mL
Geometric Coefficient of Variation 22.1
|
1.10 ng/mL
Geometric Coefficient of Variation 130
|
1.20 ng/mL
Geometric Coefficient of Variation 112
|
PRIMARY outcome
Timeframe: 27 daysPopulation: PK population excluding subjects with reported emesis - Subjects with values for Cmax,ss excluding subjects with reported emesis
Cmax,ss = maximum observed concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)
|
0.436 ng/mL
Geometric Coefficient of Variation 20.6
|
0.463 ng/mL
Geometric Coefficient of Variation 22.8
|
1.56 ng/mL
Geometric Coefficient of Variation 26.5
|
1.61 ng/mL
Geometric Coefficient of Variation 42.6
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK population - Subjects with values for tmax
tmax = time of maximum observed plasma concentration
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=24 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)
|
4.00 hours
Interval 0.0 to 8.0
|
1.00 hours
Interval 0.5 to 2.0
|
4.00 hours
Interval 0.0 to 8.0
|
1.00 hours
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK population excluding subjects with reported emesis - Subjects with values for t\_max excluding subjects with reported emesis
tmax = time of maximum observed plasma concentration
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)
|
4.00 hours
Interval 1.0 to 8.0
|
1.00 hours
Interval 0.5 to 2.0
|
4.00 hours
Interval 2.0 to 8.0
|
1.00 hours
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK population - Subjects with values for PTF
PTF = Peak-to-trough fluctuation is measured as a percent
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=23 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)
|
112 percent
Geometric Coefficient of Variation 29.4
|
86.6 percent
Geometric Coefficient of Variation 27.5
|
101 percent
Geometric Coefficient of Variation 33.8
|
78.2 percent
Geometric Coefficient of Variation 34.5
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK population excluding subjects with reported emesis - Subjects with values for PTF excluding subjects with reported emesis
PTF = Peak-to-trough fluctuation is measured as a percent
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)
|
109 percent
Geometric Coefficient of Variation 28.9
|
86.2 percent
Geometric Coefficient of Variation 29.1
|
103 percent
Geometric Coefficient of Variation 28.3
|
82.5 percent
Geometric Coefficient of Variation 24.8
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK population - Subjects with values for Cpre,ss
Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=24 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated
|
0.507 ng/mL
Geometric Coefficient of Variation 90.4
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK population excluding subjects with reported emesis - Subjects with values for Cpre,ss excluding subjects with reported emesis
Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose
Outcome measures
| Measure |
0.375 mg q.d.ER
n=20 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
0.487 ng/mL
Geometric Coefficient of Variation 105
|
0.616 ng/mL
Geometric Coefficient of Variation 57.2
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population - Subjects with values for Cavg
Cavg = Average concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=23 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)
|
0.259 ng/mL
Geometric Coefficient of Variation 29.7
|
0.312 ng/mL
Geometric Coefficient of Variation 21.5
|
0.796 ng/mL
Geometric Coefficient of Variation 113
|
0.848 ng/mL
Geometric Coefficient of Variation 104
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population excluding subjects with reported emesis - Subjects with values for Cavg excluding subjects with reported emesis
Cavg = Average concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)
|
0.277 ng/mL
Geometric Coefficient of Variation 19.6
|
0.310 ng/mL
Geometric Coefficient of Variation 22.6
|
1.04 ng/mL
Geometric Coefficient of Variation 34.6
|
1.14 ng/mL
Geometric Coefficient of Variation 40.4
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population - Subjects with values for t1/2,ss
t1/2,ss - Apparent plasma terminal elimination half-life at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=23 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=19 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)
|
13.3 h
Geometric Coefficient of Variation 40.7
|
7.69 h
Geometric Coefficient of Variation 28.6
|
14.4 h
Geometric Coefficient of Variation 42.8
|
8.43 h
Geometric Coefficient of Variation 25.3
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population excluding subjects with reported emesis - Subjects with values for t1/2,ss excluding subjects with reported emesis
t1/2,ss - Apparent plasma terminal elimination half-life at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=19 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=20 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=14 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)
|
13.4 h
Geometric Coefficient of Variation 42.6
|
7.68 h
Geometric Coefficient of Variation 30.5
|
14.5 h
Geometric Coefficient of Variation 46.9
|
7.92 h
Geometric Coefficient of Variation 16.6
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population - Subjects with values for Cmin,ss
Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=23 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
0.478 ng/mL
Geometric Coefficient of Variation 95.3
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population excluding subjects with reported emesis - Subjects with values for Cmin,ss excluding subjects with reported emesis
Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
NA ng/mL
Geometric Coefficient of Variation NA
Pharmacokinetic parameters which could not be determined were identified by "not calculated (NC)".
|
0.403 ng/mL
Geometric Coefficient of Variation 102
|
0.609 ng/mL
Geometric Coefficient of Variation 57.2
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population - Subjects with values for CL/F,ss
CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration
Outcome measures
| Measure |
0.375 mg q.d.ER
n=23 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=23 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)
|
1007 mL/min
Geometric Coefficient of Variation 29.7
|
833 mL/min
Geometric Coefficient of Variation 21.5
|
1310 mL/min
Geometric Coefficient of Variation 113
|
1228 mL/min
Geometric Coefficient of Variation 104
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population excluding subjects with reported emesis - Subjects with values for CL/F,ss excluding subjects with reported emesis
CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=21 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=18 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)
|
942 mL/min
Geometric Coefficient of Variation 19.6
|
839 mL/min
Geometric Coefficient of Variation 22.6
|
1008 mL/min
Geometric Coefficient of Variation 34.6
|
911 mL/min
Geometric Coefficient of Variation 40.4
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population - Subjects with values for Vz/F,ss
Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration
Outcome measures
| Measure |
0.375 mg q.d.ER
n=21 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=23 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=19 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)
|
1167 L
Geometric Coefficient of Variation 50.3
|
545 L
Geometric Coefficient of Variation 40.6
|
1671 L
Geometric Coefficient of Variation 135
|
897 L
Geometric Coefficient of Variation 138
|
SECONDARY outcome
Timeframe: 27 daysPopulation: PK Population excluding subjects with reported emesis - Subjects with values for Vz/F,ss excluding subjects with reported emesis
Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration
Outcome measures
| Measure |
0.375 mg q.d.ER
n=19 Participants
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=20 Participants
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
1.5 mg q.d. ER
n=14 Participants
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=18 Participants
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)
|
1092 L
Geometric Coefficient of Variation 47.0
|
547 L
Geometric Coefficient of Variation 43.2
|
1211 L
Geometric Coefficient of Variation 37.8
|
625 L
Geometric Coefficient of Variation 45.8
|
Adverse Events
0.375 mg q.d.ER
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
0.75 mg q.d. ER Up-titration
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
1.5 mg q.d. ER
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
0.75 mg q.d. ER Down-titration
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.375 mg q.d.ER Down-titration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.125 mg t.i.d. IR
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.5 mg t.i.d. IR
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.375 mg q.d.ER
n=24 participants at risk
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.75 mg q.d. ER Up-titration
n=24 participants at risk
0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
1.5 mg q.d. ER
n=24 participants at risk
1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.75 mg q.d. ER Down-titration
n=24 participants at risk
0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.375 mg q.d.ER Down-titration
n=24 participants at risk
0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
|
0.125 mg t.i.d. IR
n=24 participants at risk
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
0.5 mg t.i.d. IR
n=24 participants at risk
0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
16.7%
4/24 • 27 days
|
12.5%
3/24 • 27 days
|
12.5%
3/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
20.8%
5/24 • 27 days
|
|
Nervous system disorders
Somnolence
|
4.2%
1/24 • 27 days
|
0.00%
0/24 • 27 days
|
25.0%
6/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
20.8%
5/24 • 27 days
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • 27 days
|
16.7%
4/24 • 27 days
|
8.3%
2/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
16.7%
4/24 • 27 days
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • 27 days
|
12.5%
3/24 • 27 days
|
20.8%
5/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
4.2%
1/24 • 27 days
|
25.0%
6/24 • 27 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • 27 days
|
4.2%
1/24 • 27 days
|
16.7%
4/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
20.8%
5/24 • 27 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • 27 days
|
16.7%
4/24 • 27 days
|
4.2%
1/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
4.2%
1/24 • 27 days
|
4.2%
1/24 • 27 days
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
12.5%
3/24 • 27 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • 27 days
|
8.3%
2/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
|
Investigations
Blood triglycerides increased
|
20.8%
5/24 • 27 days
|
0.00%
0/24 • 27 days
|
8.3%
2/24 • 27 days
|
8.3%
2/24 • 27 days
|
0.00%
0/24 • 27 days
|
20.8%
5/24 • 27 days
|
8.3%
2/24 • 27 days
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/24 • 27 days
|
4.2%
1/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
4.2%
1/24 • 27 days
|
8.3%
2/24 • 27 days
|
|
Investigations
Electrocardiogram change
|
4.2%
1/24 • 27 days
|
4.2%
1/24 • 27 days
|
0.00%
0/24 • 27 days
|
12.5%
3/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
2/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
|
Investigations
Blood glucose increased
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
8.3%
2/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • 27 days
|
12.5%
3/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
12.5%
3/24 • 27 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/24 • 27 days
|
4.2%
1/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
0.00%
0/24 • 27 days
|
4.2%
1/24 • 27 days
|
12.5%
3/24 • 27 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER