drugset / Trial / NCT01469910

Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

NCT01469910 ↗

Phase 1 Completed 63 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.

Timeline

Start
2011-09
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Simotinib Small molecule 25 mg —
Subject Simotinib Small molecule 50 mg —
Subject Simotinib Small molecule 100 mg —
Subject Simotinib Small molecule 150 mg —
Subject Simotinib Small molecule 225 mg —
Subject Simotinib Small molecule 300 mg —
Subject Simotinib Small molecule 400 mg —
Subject Simotinib Small molecule 500 mg —
Subject Simotinib Small molecule 600 mg —
Subject Simotinib Small molecule 750 mg —

Indications

No indication recorded.