At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Pramipexole manufactured in Ingelheim +1 moredrug
Likely dose
Pramipexole manufactured in Ingelheim 0.088 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence of Two Sifrol® Tablets Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
In Brief
A Phase 1 clinical trial evaluating Pramipexole manufactured in Ingelheim and Pramipexole manufactured in Ennigerloh for Healthy. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedJun 2024
Enrollment StartJul 2024
Primary CompletionAug 2024
TodayJul 2026
First PostedJun 13, 2024
Enrollment StartJul 2, 2024
Primary CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 2.1 years ago
Interventions
Pramipexole manufactured in Ingelheimdrug
1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.
Pramipexole manufactured in Ennigerlohdrug
1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.