At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multiple Dose Bioequivalence Study of Pramipexole With Increasing Doses (0.375mg to 1.5mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375mg Extended Release Tablet q.d. Versus 0.125mg Immediate Release (IR) Tablet t.i.d and 1.5 mg Extended Release Tablet q.d. Versus 0.5mg Immediate Release Tablet t.i.d. in Chinese Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating pramipexole extended release and pramipexole immediate release for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
To establish bioequivalence at steady state of: 1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status To investigate dose proportionality of pharmacokinetics parameters for: 1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.
Study Details
Timeline
Interventions
0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)