NCT01469910

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-11-10
• Last updated: 2012-07-10

Locations

1 site across 1 country: China