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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pramipexole immediate release (IR) tablets

• Registration Number: NCT02261090
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Study First Posted: 2014-10-10
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
immediate release (IR) formulation	Pramipexole immediate release (IR) tablets	-

Primary Outcome Measures

Name	Time	Method
Urine total exposure (Aeτ,ss)	up to 168 hours after each drug administration
Plasma minimum exposure (Cmin,ss)	up to 168 hours after each drug administration
Plasma peak to trough fluctuation (PTF)	up to 168 hours after each drug administration
Plasma total exposure (AUCτ,ss)	up to 168 hours after each drug administration
Plasma maximum exposure (Cmax,ss)	up to 168 hours after each drug administration
Plasma average concentration (Cavg)	up to 168 hours after each drug administration

Secondary Outcome Measures

Name	Time	Method
AUC0-6,11 for the immediate release (IR) formulation	day 7 of visit 2
Cmax for the IR formulation	up to 168 hours after drug administration in visit 2
Cmin for the IR formulation	up to 168 hours after drug administration in visit 2
tmax for the IR formulation	up to 168 hours after drug administration in visit 2
Urinary excretion (Ae) for the IR formulation	up to 168 hours after drug administration in visit 2
tmax,4 for the SR formulation	up to 96 hours after drug administration in visit 3-5, 7 and 9
t1/2,4 for the SR formulation	up to 96 hours after drug administration in visit 9
Number of subjects with adverse events	up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests	up to 8 days after last drug administration
Assessment of global tolerability by investigator on a 5-point scale	at the end of each of the visits 2 to 9
Urinary excretion (Ae) for the SR formulation	up to 168 hours after drug administration
Number of subjects with clinically significant findings in vital signs	up to 8 days after last drug administration	blood pressure, pulse rate