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

Boehringer Ingelheim24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

pramipexole extended releaseDRUG

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 releaseDRUG

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 immediate releaseDRUG

0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests 2. Age older than or equal 18 and Age younger than or equal 40 years 3. Body Mass Index larger than or equal 19 and Body Mass Index less than or equal 24kg/m2 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation. Exclusion criteria: 1. Any finding of the medical examination (including Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Surgery of the gastrointestinal tract (except appendectomy) 5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 6. History of relevant orthostatic hypotension, fainting spells or blackouts. 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 9. Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 10. Use of drugs which might reasonably influence the results of the trial up to 7 days before the start of drug administration in the study or during the study period 11. Participation in another trial with an investigational drug within one months prior to administration or during the trial 12. Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day) 13. Inability to refrain from smoking on trial days 14. Alcohol abuse (more than 40 g/day) 15. Drug abuse 16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 17. Excessive physical activities (within one week prior to administration or during the trial) 18. Any laboratory value outside the reference range that is of clinical relevance 19. Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency virus (HIV) test Exclusion criteria specific for this study: 20. Hypersensitivity to pramipexole or other dopamine agonists 21. Supine blood pressure at screening of systolic\<100 mmHg and diastolic \< 60 mmHg, or symptomatic orthostatic hypotension (i. .e. clinical symptoms of orthostatic hypotension associated with a decline \>=20 mmHg in systolic BP and a decline \>=10 mmHg in diastolic BP, at one minute after standing compared to the previous supine systolic and diastolic BP obtained after 5 minutes of quiet rest)

Locations (1)

248.665.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Outcomes

Primary Outcomes

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)

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

Time frame: 27 days

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)

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

Time frame: 27 days

Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)

Cmax = maximum observed concentration of the analyte in plasma at steady state

Time frame: 27 days

Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)

Cmax,ss = maximum observed concentration of the analyte in plasma at steady state

Time frame: 27 days

Secondary Outcomes

Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)

tmax = time of maximum observed plasma concentration

Time frame: 27 days

Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)

Data from ClinicalTrials.gov

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