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

Healthy Clinical Trial

Official title:

Bioequivalence of Two Sifrol® Tablets Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457204
• Other study ID #: 0248-0689
• Secondary ID: 2024-510764-23-0
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 27, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pramipexole (from manufacturing site 1)
Pramipexole (from manufacturing site 1) - test treatment
• Pramipexole (from manufacturing site 2)
Pramipexole (from manufacturing site 2) - reference treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum measured concentration of the analyte in plasma (Cmax)		up to 3 days
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 3 days

External Links

•   Related Info