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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Formulation G: Pramipexole Slow release tablet; Drug: Formulation F: Pramipexole Slow release tablet; Drug: Formulation D: Pramipexole Slow release tablet; Drug: Formulation H: Pramipexole Slow release tablet; Drug: Formulation B: Pramipexole Slow release (SR) tablet; Drug: Pramipexole immediate release (IR) tablets; Drug: Formulation E: Pramipexole Slow release tablet; Drug: Formulation C: Pramipexole Slow release tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261090

248.529

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 8 patient groups

Formulation B

Experimental group

Description:

Slow release (SR) tablet

Treatment:

Drug: Formulation B: Pramipexole Slow release (SR) tablet

Formulation C

Experimental group

Description:

SR tablet

Treatment:

Drug: Formulation C: Pramipexole Slow release tablet

Formulation D

Experimental group

Description:

SR tablet

Treatment:

Drug: Formulation D: Pramipexole Slow release tablet

Formulation E

Experimental group

Description:

SR tablet

Treatment:

Drug: Formulation E: Pramipexole Slow release tablet

Formulation F

Experimental group

Description:

SR tablet

Treatment:

Drug: Formulation F: Pramipexole Slow release tablet

Formulation G

Experimental group

Description:

SR tablet

Treatment:

Drug: Formulation G: Pramipexole Slow release tablet

Formulation H

Experimental group

Description:

SR tablet

Treatment:

Drug: Formulation H: Pramipexole Slow release tablet

immediate release (IR) formulation

Active Comparator group

Treatment:

Drug: Pramipexole immediate release (IR) tablets