healthy male
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. male; 2. Aged between 18 and 30 years, extremes included; 3. Normal weight as defined by a Quetelet Index (BMI)range of 19.0 - 25.0, extremes included; 4. Non-smokers or occasional smokers (defined as smoking no more than 10 cigarettes per week); 5. Healthy on the basis of a medical history, vital signs, physical examination, electrocardiogram (ECG), and the results of clinical laboratory tests carried out within 1 week prior to the first dosing. 6. Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study and were willing to adhere to the treatment regimen and study procedure described in this protocol; 7. No other drugs were taken within 2 week prior to the first dosing.
Exclusion criteria
Exclusion criteria: 1. History of cardiac arrhythmia, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, parkinsonism, or any other disease or physical condition which could have interfered with the interpretation of the study results; 2. Known significant bleeding diathesis which could have precluded multiple venipunctures; Any gastrointestinal condition that could have affected drug absorption or metabolism; 3. History of drug abuse within past 5 years or positive urine drug screen results; 4. Use of concomitant medication within 14 days before the first dose; Participation in an investigational drug trial within 30 days prior to the first visit or intention to take another investigational drug during the course of the study; 5. Significant loss or donation of blood or plasma (500 mL) within 30 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indices of pharmacokinetics;Indices of pharmacodynamics; | — |
Countries
China