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Completed

NCT Number: NCT02264132

Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet 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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pramipexole ER tablet

Drug

Pramipexole IR tablet

Drug

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  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)

    Time frame: up to 24 hours after drug administration

    Dose proportionality (only for ER)

  3. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)

    Time frame: up to day 5

    Dose proportionality (only for ER)

  4. 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)

  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)

    Time frame: up to 24 hours after drug administration

  6. 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

  7. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)

    Time frame: up to day 5

  8. Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)

    Time frame: up to day 5

  9. PTF (peak-trough fluctuation)

    Time frame: up to day 5

  10. tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)

    Time frame: up to day 5

  11. 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

  12. Cavg (average concentration of the analyte in plasma at steady state)

    Time frame: up to day 5

  13. t1/2,ss (terminal half-life of the analyte in plasma at steady state)

    Time frame: up to day 5

  14. CL/F,ss (apparent clearance of the analyte in plasma at steady state after

    Time frame: up to day 5

  15. CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)

    Time frame: up to day 5

  16. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)

    Time frame: up to day 5

  17. 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

  18. 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

  19. 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

  20. Number of subjects with adverse events

    Time frame: up to 7 days after last drug administration

  21. Assessment of tolerability by investigator on a 4-point scale

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
First posted
Oct 15, 2014
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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