Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.
Eligibility Criteria
Inclusion
- Healthy , male or female subjects
- Age of 18 to 45 years
- Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight \> 50 kg for male, \> 45 kg for female
- Written informed consent signed and dated by the subject
- Subjects who are willing and able to comply with study procedures
Exclusion
- Any clinically significant disease or surgery within 4 weeks prior to the beginning of the study
- Known hypersensitivity to the study drug or similar drugs
- History of any serious disease, including but not limited to circulatory system, endocrine system, central nervous system, hematology, immunology, metabolic diseases and psychiatric disorders
- History of gastrointestinal, hepatic, and renal diseases, affecting drug absorption and metabolism
- Any clinically significant abnormal clinical laboratory tests
- Abnormal ECG or vital signs
- A positive test for HIV antibody
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
- History of alcohol consumption within six months of the study defined as: an average weekly intake of \> 14 units
- History of regular tobacco use or nicotine containing products within three months prior to screening
- Consumption of too much tea or coffee (\> 8 cups/day)
- Use of any drug, which inhibits or induces hepatic drug metabolism, within 30 days prior to the beginning of the study
- Use of any drug within 14 days prior to the beginning of the study
- Participate in other clinical trials within 30 days prior to the beginning of the study
- Blood donation within 30 days of dosing
- All female subjects must not be of child-bearing potential
- Pregnant or lactating women
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01469910
Start Date
September 1 2011
End Date
June 1 2012
Last Update
July 10 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013