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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06457204

2024-510764-23-00 (Registry Identifier)

U1111-1303-3852 (Registry Identifier)

0248-0689

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Reference - Test

Experimental group

Description:

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.

Treatment:

Drug: Pramipexole manufactured in Ingelheim

Drug: Pramipexole manufactured in Ennigerloh

Test - Reference

Experimental group

Description:

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.

Treatment:

Drug: Pramipexole manufactured in Ingelheim

Drug: Pramipexole manufactured in Ennigerloh