Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters

Relative BA at steady state:

• Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.

• Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.

Dose proportionality of pharmacokinetic parameters:

· Pramipexole ER dosages from 0.375 to 1.5 mg q.d.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pramipexole

Criteria

Inclusion Criteria:

• All subjects participating in the study are healthy male volunteers

• Age between 20 and 40 years

• Body mass index (BMI) between 17.6 and 26.4 kg/m2

• All volunteers must give written informed consent before screening to participate in this study and before first drug administration on Day 1 at Visit 2

Exclusion Criteria:

• Any findings of the medical examination (including blood pressure, pulse rate, ECG, and laboratory test parameters) of clinical relevance

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders

• History of orthostatic hypotension, fainting spells or blackouts

• Chronic or acute infections

• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

• Intake of drugs with a long half-life (>24 hours) within at least one month or less than ten half-lives of the respective drug before the administration of investigational products

• Use of any drugs which might influence the results of the trial within 7 days before the start of drug administration in the study or during the study period

• Participation in another trial with an investigational drug (within 4 months before the start of drug administration)

• Smoker (>10 cigarettes or >3 cigars or >3 pipes/day and who cannot refrain from smoking at the trial site)

• Alcohol abuse (>40 g/day)

• Drug abuse

• Blood donation (≥100 mL within 4 weeks before drug administration or during the trial)

• Excessive physical activities from 7 days before the start of drug administration to the end of this study

• 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

The following exclusion criteria are of special interest for this study:

• Hypersensitivity to pramipexole or other dopamine agonists

• Supine blood pressure at screening of systolic <110 mmHg and diastolic <60 mmHg