Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02261103
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Multiple Dose Study With Increasing Pramipexole Doses (0.375 mg to 4.5 mg q.d.) of Oral Extended Release (ER) Tablets With a Three-way Cross Comparison of 4.5 mg Pramipexole ER q.d. Fasted Versus 4.5 mg Pramipexole ER q.d. Fed Versus 1.5 mg Pramipexole Immediate Release Tablets t.i.d. Fasted in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of the studies are:
* To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
* To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
* To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing
* To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
* To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
* To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: