Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02264132
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pramipexole IR tablet versus Pramipexole ER tablet Pramipexole ER tablet - Pramipexole ER tablet versus Pramipexole IR tablet Pramipexole ER tablet - Pramipexole ER tablet versus Pramipexole IR tablet Pramipexole IR tablet - Pramipexole IR tablet versus Pramipexole ER tablet Pramipexole IR tablet -
- Primary Outcome Measures
Name Time Method 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) 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.) up to 24 hours after drug administration
- Secondary Outcome Measures
Name Time Method CL/F,ss (apparent clearance of the analyte in plasma at steady state after 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.) 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) up to 24 hours after drug administration Cmin,ss (minimum measured concentration of the analyte in plasma at steady state) up to day 5 tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state) up to day 5 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) up to 24 hours after drug administration Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) up to day 5 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) up to 8 hours after drug administration Number of subjects with adverse events up to 7 days after last drug administration PTF (peak-trough fluctuation) up to day 5 t1/2,ss (terminal half-life of the analyte in plasma at steady state) up to day 5 Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) up to day 5 Cavg (average concentration of the analyte in plasma at steady state) up to day 5 Assessment of tolerability by investigator on a 4-point scale Day 5 CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ) up to day 5 Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration) up to day 5 Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state) up to 8 hours after drug administration