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

NCT ID: NCT01214109

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

pramipexole extended release

Intervention Type: DRUG

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 release

Intervention Type: DRUG

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

pramipexole immediate release

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

Group Type: ACTIVE_COMPARATOR

pramipexole extended release

Intervention Type: DRUG

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 release

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

pramipexole immediate release

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

Intervention Type: DRUG

pramipexole immediate release

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

Intervention Type: DRUG

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

248.665.86002 Boehringer Ingelheim Investigational Site

Beijing, , China

Countries

China

Other Identifiers

248.665

Identifier Type: -

Identifier Source: org_study_id