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CompletedNCT02264132Updated Oct 15, 2014

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

A Phase 1 interventional study of Pramipexole ER tablet and Pramipexole IR tablet in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Pramipexole ER tablet versus Pramipexole IR tablet

    Drug: Pramipexole ER tablet · Drug: Pramipexole IR tablet

  • Experimental
    Pramipexole IR tablet versus Pramipexole ER tablet

    Drug: Pramipexole ER tablet · Drug: Pramipexole IR tablet

Interventions

  • DrugPramipexole ER tablet
  • DrugPramipexole IR tablet
06

What researchers measure

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)

    Relative BA

    Time frame: up to 24 hours after drug administration

  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)

    Dose proportionality (only for ER)

    Time frame: up to 24 hours after drug administration

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

    Dose proportionality (only for ER)

    Time frame: up to day 5

  4. Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)

    Dose proportionality (only for ER)

    Time frame: up to 24 hours after drug administration

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02264132
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 15, 2014
Start date
Sep 2006
Primary completion
Nov 2006
Last update
Oct 15, 2014
View the source record on ClinicalTrials.gov ↗

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