Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: pramipexole extended release; Drug: pramipexole immediate release

• Registration Number: NCT01214109
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To establish bioequivalence at steady state of:

1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status

To investigate dose proportionality of pharmacokinetics parameters for:

1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Study Start: 2010-12
• Primary Completion: 2011-01
• Results First Submitted: 2012-01-25
• Results First Submitted QC: 2012-01-25
• Results First Posted: 2012-02-27
• Status Verified: 2014-03
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pramipexole immediate release	pramipexole extended release	0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
pramipexole immediate release	pramipexole immediate release	0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
pramipexole extended release	pramipexole extended release	0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
pramipexole extended release	pramipexole immediate release	0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)

Primary Outcome Measures

Name	Time	Method
Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)	27 days	Cmax = maximum observed concentration of the analyte in plasma at steady state
Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)	27 days	Cmax,ss = maximum observed concentration of the analyte in plasma at steady state
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)	27 days	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
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)	27 days	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

Secondary Outcome Measures

Name	Time	Method
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)	27 days	tmax = time of maximum observed plasma concentration
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)	27 days	Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration
Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)	27 days	PTF = Peak-to-trough fluctuation is measured as a percent
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)	27 days	Cavg = Average concentration of the analyte in plasma at steady state
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)	27 days	CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration
Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)	27 days	PTF = Peak-to-trough fluctuation is measured as a percent
Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)	27 days	Cavg = Average concentration of the analyte in plasma at steady state
Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)	27 days	tmax = time of maximum observed plasma concentration
Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)	27 days	Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose
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)	27 days	Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)	27 days	t1/2,ss - Apparent plasma terminal elimination half-life at steady state
Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)	27 days	Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state
Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)	27 days	t1/2,ss - Apparent plasma terminal elimination half-life at steady state
Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)	27 days	Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state
The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)	27 days	CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration
Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)	27 days	Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration

Trial Locations

Locations (1)

248.665.86002 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China