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Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers

Venous Thrombosis Clinical Trial

Official title:
Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA 136 Tablets in Healthy Subjects

Clinical Trial Summary

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study.

The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04036656
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date August 2019
Completion date May 2020
View Details
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