A Study in Healthy People to Compare Two Different Sifrol® Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pramipexole (from manufacturing site 1); Drug: Pramipexole (from manufacturing site 2)

• Registration Number: NCT06457204
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Study Start: 2024-06-27
• Status Verified: 2024-08
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical histo1y including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 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 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 Further exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence A	Pramipexole (from manufacturing site 2)	First reference treatment, then test treatment
Treatment sequence A	Pramipexole (from manufacturing site 1)	First reference treatment, then test treatment
Treatment sequence B	Pramipexole (from manufacturing site 1)	First test treatment, then reference treatment
Treatment sequence B	Pramipexole (from manufacturing site 2)	First test treatment, then reference treatment

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	up to 3 days
Maximum measured concentration of the analyte in plasma (Cmax)	up to 3 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 3 days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany