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

NCT06457204 | Completed Phase 1 Results

• 3 other identifiers: 0248-06892024-510764-23-00U1111-1303-3852
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of pramipexole in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.

  Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration.

• Maximum Measured Concentration of Pramipexole in Plasma (Cmax)

  Maximum measured concentration of pramipexole in plasma (Cmax). Data was derived from an Analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' were considered as random, whereas the other effects were considered as fixed. CIs were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.

  Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of Pramipexole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within 3 hours prior to drug administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours following administration.

Study Arms (2)

Reference - Test

EXPERIMENTAL

Subjects received the reference product followed by the test product, the treatments were separated by a wash-out phase of at least 3 days. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Drug: Pramipexole manufactured in Ingelheim; Drug: Pramipexole manufactured in Ennigerloh

Test - Reference

EXPERIMENTAL

Subjects received the test product followed by the reference product, the treatments were separated by a wash-out phase of at least 3 days. Test product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours. Reference product: Healthy subjects received 1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Drug: Pramipexole manufactured in Ingelheim; Drug: Pramipexole manufactured in Ennigerloh

Interventions

Pramipexole manufactured in Ingelheim DRUG

1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Also known as: Sifrol® Tabletten

Reference - Test; Test - Reference

Pramipexole manufactured in Ennigerloh DRUG

1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Also known as: Sifrol® Tabletten

Reference - Test; Test - Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: July 2, 2024
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)