Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers

NCT ID: NCT02261090

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

Brief Summary

Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets

Conditions

Healthy

Study Design

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

Study Groups

Formulation B

Slow release (SR) tablet

Group Type: EXPERIMENTAL

Formulation B: Pramipexole Slow release (SR) tablet

Intervention Type: DRUG

Formulation C

SR tablet

Group Type: EXPERIMENTAL

Formulation C: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation D

SR tablet

Group Type: EXPERIMENTAL

Formulation D: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation E

SR tablet

Group Type: EXPERIMENTAL

Formulation E: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation F

SR tablet

Group Type: EXPERIMENTAL

Formulation F: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation G

SR tablet

Group Type: EXPERIMENTAL

Formulation G: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation H

SR tablet

Group Type: EXPERIMENTAL

Formulation H: Pramipexole Slow release tablet

Intervention Type: DRUG

immediate release (IR) formulation

Group Type: ACTIVE_COMPARATOR

Pramipexole immediate release (IR) tablets

Intervention Type: DRUG

Interventions

Formulation B: Pramipexole Slow release (SR) tablet

Intervention Type: DRUG

Formulation C: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation D: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation E: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation F: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation G: Pramipexole Slow release tablet

Intervention Type: DRUG

Formulation H: Pramipexole Slow release tablet

Intervention Type: DRUG

Pramipexole immediate release (IR) tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All participants in the study should be healthy males
• Participants should be ranging from 21 to 50 years of age
• Body mass index (BMI) within 18.5 to 29.9 kg/m2
• In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant 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 (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on in-house trial days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
• Any laboratory value outside the clinically accepted reference range
• Excessive physical activities within the last week before the trial or during the trial
• Hypersensitivity to pramipexole, or other dopamine agonists
• Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
• A haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal for males: 12.6 g/mL)
• Subjects involved in passenger transport or operation of dangerous machines

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

248.529

Identifier Type: -

Identifier Source: org_study_id