Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers

NCT02264132 | Completed Phase 1

• 1 other identifier: 248.607
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• 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

• 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

• 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

• 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

Study Arms (2)

Pramipexole ER tablet versus Pramipexole IR tablet

EXPERIMENTAL

Drug: Pramipexole ER tablet; Drug: Pramipexole IR tablet

Pramipexole IR tablet versus Pramipexole ER tablet

EXPERIMENTAL

Drug: Pramipexole ER tablet; Drug: Pramipexole IR tablet

Interventions

Pramipexole ER tablet DRUG

Pramipexole ER tablet versus Pramipexole IR tablet; Pramipexole IR tablet versus Pramipexole ER tablet

Pramipexole IR tablet DRUG

Pramipexole ER tablet versus Pramipexole IR tablet; Pramipexole IR tablet versus Pramipexole ER tablet

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2006
• Primary Completion: November 1, 2006
• Last Updated: October 15, 2014

Record last verified: 2014-10