CompletedNCT02261090Updated Oct 10, 2014

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

A Phase 1 interventional study of Formulation B: Pramipexole Slow release (SR) tablet and Formulation C: Pramipexole Slow release tablet in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-10.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: Male

Study summary

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

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

Experimental
Formulation B
Slow release (SR) tablet
Drug: Formulation B: Pramipexole Slow release (SR) tablet
Experimental
Formulation C
SR tablet
Drug: Formulation C: Pramipexole Slow release tablet
Experimental
Formulation D
SR tablet
Drug: Formulation D: Pramipexole Slow release tablet
Experimental
Formulation E
SR tablet
Drug: Formulation E: Pramipexole Slow release tablet
Experimental
Formulation F
SR tablet
Drug: Formulation F: Pramipexole Slow release tablet
Experimental
Formulation G
SR tablet
Drug: Formulation G: Pramipexole Slow release tablet
Experimental
Formulation H
SR tablet
Drug: Formulation H: Pramipexole Slow release tablet
Active comparator
immediate release (IR) formulation
Drug: Pramipexole immediate release (IR) tablets

Interventions

DrugFormulation B: Pramipexole Slow release (SR) tablet
DrugFormulation C: Pramipexole Slow release tablet
DrugFormulation D: Pramipexole Slow release tablet
DrugFormulation E: Pramipexole Slow release tablet
DrugFormulation F: Pramipexole Slow release tablet
DrugFormulation G: Pramipexole Slow release tablet
DrugFormulation H: Pramipexole Slow release tablet
DrugPramipexole immediate release (IR) tablets

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02261090
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Oct 10, 2014
Start date: Jun 2004
Primary completion: Sep 2004
Last update: Oct 10, 2014

View the source record on ClinicalTrials.gov ↗

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