NCT03113084

Study With Heparin Sodium in Subcutaneous Administration

Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: União Química Farmacêutica Nacional S/A · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide. Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.

Conditions

• Heparin

Interventions

Type	Name	Description
BIOLOGICAL	Sodium Heparin UQ subcutaneous drug administration	The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
BIOLOGICAL	Sodium Heparin FK subcutaneous drug administration	The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas

Timeline

• Start date: 2022-08-20
• Primary completion: 2023-04-20
• Completion: 2023-10-10
• First posted: 2017-04-13
• Last updated: 2019-10-14

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study