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

NCT02264132 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-10-15

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Pramipexole ER tablet

DRUG

Pramipexole IR tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264132 on ClinicalTrials.gov