- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261103
Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers
October 9, 2014 updated by: Boehringer Ingelheim
A Multiple Dose Study With Increasing Pramipexole Doses (0.375 mg to 4.5 mg q.d.) of Oral Extended Release (ER) Tablets With a Three-way Cross Comparison of 4.5 mg Pramipexole ER q.d. Fasted Versus 4.5 mg Pramipexole ER q.d. Fed Versus 1.5 mg Pramipexole Immediate Release Tablets t.i.d. Fasted in Healthy Male Volunteers
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pramipexole IR, fasted
Pramipexole immediate release (IR) tablets
|
|
Experimental: Pramipexole ER, fasted
Pramipexole extended release (ER) tablets
|
|
Experimental: Pramipexole ER, fed
Pramipexole extended release tablets with a high-fat meal 30 min before drug administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
AUC0-24,ss for IR
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Maximum measured concentration of the analyte in plasma at steady state (Cmax)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 4h at steady state (AUC0-4,ss) for ER
Time Frame: up to 4 hours after drug application
|
up to 4 hours after drug application
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Peak-Trough Fluctuation (PTF)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Time from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 h at steady state (AUC0-8,ss)
Time Frame: up to 8 hours after drug application
|
up to 8 hours after drug application
|
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time Frame: predose on days 1 to 5
|
predose on days 1 to 5
|
Average concentration of the analyte in plasma at steady state (Cavg)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTpo,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 24 (Ae0-24,ss)
Time Frame: up to 23 hours after drug application on day 5
|
up to 23 hours after drug application on day 5
|
Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 8 (Ae0-8,ss) for IR
Time Frame: up to 8 hours after drug application on day 5
|
up to 8 hours after drug application on day 5
|
Number of subjects with adverse events
Time Frame: up to 7 days after last drug administration
|
up to 7 days after last drug administration
|
Number of subjects with clinically relevant changes in vital signs
Time Frame: up to 7 days after last drug administration
|
up to 7 days after last drug administration
|
Number of subjects with clinically relevant changes in laboratory parameters
Time Frame: up to 7 days after last drug administration
|
up to 7 days after last drug administration
|
Assessment of global tolerability by investigator on a 4-point scale
Time Frame: day 5 of each visit
|
day 5 of each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
October 9, 2014
First Submitted That Met QC Criteria
October 9, 2014
First Posted (Estimate)
October 10, 2014
Study Record Updates
Last Update Posted (Estimate)
October 10, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248.530
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Pramipexole IR tablets
-
Boehringer IngelheimCompleted
-
Cerevel Therapeutics, LLCRecruitingHealthy ParticipantsUnited States
-
Boehringer IngelheimCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Janssen Research & Development, LLCCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Boehringer IngelheimCompletedParkinson Disease
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompletedRestless Legs SyndromeJapan