drugset / Trial / NCT03125187
Study With Heparin Sodium in Intravenous Administration
Phase 1
Suspended
24 enrolled
Uniao Quimica
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME · collab
RandomizedCrossoverOpen-labelOther
Summary
The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous application in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.
Timeline
- Start
- 2021-02-20
- Primary completion
- 2021-02-20
- Completion
- 2022-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Heparin | Other / unclassified | — | Intravenous |
Indications
No indication recorded.