Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers

NCT ID: NCT02261103

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30

Brief Summary

The objectives of the studies are:

• To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
• To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
• To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pramipexole IR, fasted

Pramipexole immediate release (IR) tablets

Group Type: ACTIVE_COMPARATOR

Pramipexole IR tablets

Intervention Type: DRUG

Placebo matching Pramipexole ER tablets

Intervention Type: DRUG

Pramipexole ER, fasted

Pramipexole extended release (ER) tablets

Group Type: EXPERIMENTAL

Pramipexole ER tablets

Intervention Type: DRUG

Placebo matching Pramipexole IR tablets

Intervention Type: DRUG

Pramipexole ER, fed

Pramipexole extended release tablets with a high-fat meal 30 min before drug administration

Group Type: EXPERIMENTAL

Pramipexole ER tablets

Intervention Type: DRUG

Standard high-fat breakfast

Intervention Type: OTHER

Interventions

Pramipexole ER tablets

Intervention Type: DRUG

Pramipexole IR tablets

Intervention Type: DRUG

Placebo matching Pramipexole ER tablets

Intervention Type: DRUG

Placebo matching Pramipexole IR tablets

Intervention Type: DRUG

Standard high-fat breakfast

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants in the study should be healthy males
• Age range from 21 to 50 years
• Body mass index (BMI) be 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 (≤ one month 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 (> 40 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

• 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

248.530

Identifier Type: -

Identifier Source: org_study_id