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

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Healthy
Interventions
DRUG

Simotinib Hydrochloride

Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

DRUG

Placebo

Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Trial Locations (1)

410013

The Third Xiangya Hospital of Central South University, Changsha

All Listed Sponsors
lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY