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A Study in Healthy Men to Compare 2 Different Formulations of Alteplase

NCT04419493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-26

Study results available
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Summary

To establish the bioequivalence of alteplase derived from two different manufacturing processes.

Conditions

  • Healthy

Interventions

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2021-06-21
Completion
2021-06-21

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04419493 on ClinicalTrials.gov