A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole | NCT07727785

NCT07727785

Overview

NCT ID: NCT07727785
Lead Sponsor: Boehringer IngelheimINDUSTRY
Official Title: Bioequivalence of Two Pramipexole Tablets Following Oral Administration in Healthy Participants (an Open-label, Randomised, Multiple-dose, Two-way Crossover Trial)
Brief Summary: The goal of this study is to find out whether pramipexole tablets made at two different production sites are handled in the same way by the body.
Conditions: Healthy
Interventions: Sifrol®
Mirapex®

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion criteria:

Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), and 12-lead electrocardiogram (ECG)

Age of 18 to 55 years (inclusive)

Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)

Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Further inclusion criteria apply.

Exclusion criteria:

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeters of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)

Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Further exclusion criteria apply.

Central Contacts: Boehringer IngelheimContact
clintriage.rdg@boehringer-ingelheim.com