Trials / Completed
CompletedNCT04419493
A Study in Healthy Men to Compare 2 Different Formulations of Alteplase
Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To establish the bioequivalence of alteplase derived from two different manufacturing processes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alteplase (from modified manufacturing process) | Alteplase, TPA-05 |
| DRUG | Alteplase (from current manufacturing process) | Alteplase, TPA-02 |
| DRUG | Heparin-Natrium-5000-ratiopharm (unfractionated heparin) | Heparin-Natrium-5000-ratiopharm (unfractionated heparin) |
Timeline
- Start date
- 2020-06-23
- Primary completion
- 2021-06-21
- Completion
- 2021-06-21
- First posted
- 2020-06-05
- Last updated
- 2023-04-26
- Results posted
- 2023-04-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04419493. Inclusion in this directory is not an endorsement.