At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Alteplase (from modified manufacturing process) +2 moredrug
Likely dose
Not stated in 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 Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating Alteplase (from modified manufacturing process), Alteplase (from current manufacturing process), and 1 other intervention for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed Summary
To establish the bioequivalence of alteplase derived from two different manufacturing processes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJun 2020
Primary CompletionJun 2021
TodayJul 2026
First PostedJun 5, 2020
Enrollment StartJun 23, 2020
Primary CompletionJun 21, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.1 years ago
Interventions
Alteplase (from modified manufacturing process)drug
Alteplase, TPA-05
Alteplase (from current manufacturing process)drug
Alteplase, TPA-02
Heparin-Natrium-5000-ratiopharm (unfractionated heparin)drug
Heparin-Natrium-5000-ratiopharm (unfractionated heparin)