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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pramipexole ER tablets; Drug: Placebo matching Pramipexole ER tablets; Drug: Placebo matching Pramipexole IR tablets; Drug: Pramipexole IR tablets; Other: Standard high-fat breakfast

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261103

248.530

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Pramipexole IR, fasted

Active Comparator group

Description:

Pramipexole immediate release (IR) tablets

Treatment:

Drug: Pramipexole IR tablets

Drug: Placebo matching Pramipexole ER tablets

Pramipexole ER, fasted

Experimental group

Description:

Pramipexole extended release (ER) tablets

Treatment:

Drug: Pramipexole ER tablets

Drug: Placebo matching Pramipexole IR tablets

Pramipexole ER, fed

Experimental group

Description:

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

Treatment:

Other: Standard high-fat breakfast

Drug: Pramipexole ER tablets