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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Pramipexole IR tablet

Drug: Pramipexole ER tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT02264132

248.607

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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