drugset / Trial / NCT03113084
Study With Heparin Sodium in Subcutaneous Administration
Phase 1
Suspended
38 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 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
- 2022-08-20
- Primary completion
- 2023-04-20
- Completion
- 2023-10-10
Outcome
Outcome not reported
Stopped: “Delay in the R\&D stage”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Heparin FK | Unknown | — | Subcutaneous |
| Subject | Sodium Heparin UQ | Unknown | — | Subcutaneous |