NCT02261103

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

Completed Phase 1 Last updated 9 October 2014

What this trial tests

Phase 1 trial testing Pramipexole ER tablets in Healthy in 39 participants. Completed.

Timeline

1 April 2006

Primary endpoint
1 July 2006

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	39
Start date	1 April 2006
Primary completion	1 July 2006

Drugs / interventions tested

• Pramipexole ER tablets — full drug profile →
• Pramipexole IR tablets — full drug profile →
• Placebo matching Pramipexole ER tablets — full drug profile →
• Placebo matching Pramipexole IR tablets — full drug profile →
• Standard high-fat breakfast

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 21 to 50, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER
  Time frame: up to 23 hours after drug application on day 5
• AUC0-24,ss for IR
  Time frame: up to 23 hours after drug application on day 5
• Maximum measured concentration of the analyte in plasma at steady state (Cmax)
  Time frame: up to 23 hours after drug application on day 5
• Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 4h at steady state (AUC0-4,ss) for ER
  Time frame: up to 4 hours after drug application

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Clinical Trial.
   Yang L, Zhang L, Luo Z. · · 2023 · PMID 37600497 · DOI 10.2147/dddt.s421449