Healthy
Conditions
Brief summary
The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.
Interventions
Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg
DRUGPlacebo
Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | within 7 days following administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| The maximum plasma concentration (Cmax) | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h |
| The time to Cmax (tmax) | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h |
| Area under the plasma concentration-time curve (AUC) | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h |
| The Terminal half-life (t1/2) | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h |
Countries
China
Outcome results
None listed