NCT06457204

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2024-07-02
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2024-06-13
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

1 site across 1 country: Germany