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

Bioequivalence of Two Pramipexole Tablets Following Oral Administration in Healthy Participants (an Open-label, Randomised, Multiple-dose, Two-way Crossover Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Sifrol®; Drug: Mirapex®

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Recruiting
    • Humanpharmakologisches Zentrum Biberach
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. 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)
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
4. 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
5. Further inclusion criteria apply.

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence A	Drug: Sifrol®; Pramipexole tablets; Other Names: Pramipexole; Drug: Mirapex®; Pramipexole tablets; Other Names: Pramipexole
Experimental: Treatment sequence B	Drug: Sifrol®; Pramipexole tablets; Other Names: Pramipexole; Drug: Mirapex®; Pramipexole tablets; Other Names: Pramipexole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)	Up to Day 11
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)	Up to Day 11

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)	Up to Day 11
Time from dosing to minimum measured concentration of the analyte in plasma at steady state within a uniform dosing interval τ (tmin,ss)	Up to Day 11
Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss)	Up to Day 11
Average concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cavg)	Up to Day 11
Measured concentration of the analyte in plasma at steady state at timepoint (= end of interval) τ (Cτ,ss)	Up to Day 11
Peak-trough fluctuation (PTF)	Up to Day 11
Peak-trough swing (PTS)	Up to Day 11

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2026
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Benzothiazoles; Azoles; Pramipexole
• Other Study ID Numbers: 0248-0690; U1111-1335-9014 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP)); 2026-525704-98 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No