- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02264132
Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers
October 14, 2014 updated by: Boehringer Ingelheim
A Multiple Dose Study of Pramipexole With Increasing Doses (0.375 mg to 1.5 mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375 mg ER Tablet q.d. Versus 0.125 mg Immediate Release (IR) Tablet t.i.d. and 1.5 mg ER Tablet q.d. Versus 0.5 mg IR Tablet t.i.d. in Japanese Healthy Male Volunteers
The objectives of this study were to investigate relative BA at steady state and to investigate dose proportionality of pharmacokinetic parameters
Relative BA at steady state:
- Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.
- Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.
Dose proportionality of pharmacokinetic parameters:
· Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All subjects participating in the study are healthy male volunteers
- Age between 20 and 40 years
- Body mass index (BMI) between 17.6 and 26.4 kg/m2
- All volunteers must give written informed consent before screening to participate in this study and before first drug administration on Day 1 at Visit 2
Exclusion Criteria:
- Any findings of the medical examination (including blood pressure, pulse rate, ECG, and laboratory test parameters) of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or 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 hours) within at least one month or less than ten half-lives of the respective drug before the administration of investigational products
- Use of any drugs which might influence the results of the trial within 7 days before the start of drug administration in the study or during the study period
- Participation in another trial with an investigational drug (within 4 months before the start of drug administration)
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day and who cannot refrain from smoking at the trial site)
- Alcohol abuse (>40 g/day)
- Drug abuse
- Blood donation (≥100 mL within 4 weeks before drug administration or during the trial)
- Excessive physical activities from 7 days before the start of drug administration to the end of this study
- Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency virus (HIV) test
The following exclusion criteria are of special interest for this study:
- 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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pramipexole ER tablet versus Pramipexole IR tablet
|
|
EXPERIMENTAL: Pramipexole IR tablet versus Pramipexole ER tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Time Frame: up to day 5
|
up to day 5
|
AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events
Time Frame: up to 7 days after last drug administration
|
up to 7 days after last drug administration
|
|
AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time Frame: up to 24 hours after drug administration
|
Relative BA
|
up to 24 hours after drug administration
|
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Time Frame: up to 24 hours after drug administration
|
Dose proportionality (only for ER)
|
up to 24 hours after drug administration
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time Frame: up to day 5
|
Dose proportionality (only for ER)
|
up to day 5
|
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time Frame: up to 24 hours after drug administration
|
Dose proportionality (only for ER)
|
up to 24 hours after drug administration
|
AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time Frame: up to day 5
|
up to day 5
|
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)
Time Frame: up to day 5
|
up to day 5
|
|
PTF (peak-trough fluctuation)
Time Frame: up to day 5
|
up to day 5
|
|
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)
Time Frame: up to day 5
|
up to day 5
|
|
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time Frame: up to day 5
|
up to day 5
|
|
Cavg (average concentration of the analyte in plasma at steady state)
Time Frame: up to day 5
|
up to day 5
|
|
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time Frame: up to day 5
|
up to day 5
|
|
CL/F,ss (apparent clearance of the analyte in plasma at steady state after
Time Frame: up to day 5
|
up to day 5
|
|
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Time Frame: up to day 5
|
up to day 5
|
|
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
Time Frame: up to day 5
|
up to day 5
|
|
Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state)
Time Frame: up to 8 hours after drug administration
|
up to 8 hours after drug administration
|
|
AUC0-8,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 hours at steady state)
Time Frame: up to 8 hours after drug administration
|
up to 8 hours after drug administration
|
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: Day 5
|
Day 5
|
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
September 1, 2006
Primary Completion (ACTUAL)
November 1, 2006
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
October 14, 2014
First Posted (ESTIMATE)
October 15, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
October 15, 2014
Last Update Submitted That Met QC Criteria
October 14, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248.607
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.
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