Healthy subject
Conditions
Interventions
0.25 mg/kg:Single intravenous administration of pilsicainide 0.25 mg/kg and collect blood and urine samples before and after dosing to assess the Pharmacokinetical parameters.
0.50 mg/kg:Single intravenous administration of pilsicainide 0.50 mg/kg and collect blood and urine samples before and after dosing to assess the Pharmacokinetical parameters.
0.75 mg/kg:Single intravenous administration of pilsicainide 0.75 mg/kg and collect blood and urine samples before and after dosing to assess the Pharmacokinetical parameters.
Sponsors
Drug Clinical Trials Institute of Beijing Anzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Be able to make good communication with researchers. Understand and comply with the various requirements of the present study. Understood and signed the informed consent; 2) Chinese healthy subjects, 18 to 45 years old. Have a good health condition, according to the disease history, physical test, vital signs, ECG and clinical laboratory tests; 3) BMI is in normal range. Have a weight over 55 kg for male, and over 45 kg for female. The weight should below 80 kg; 4) The vital signs should meeting the following criteria: axillary temperature, 35 to 37 degrees C; SBP 90 to 140 mmHg; DBP 60 to 90 mmHg; Heart rate, 60 to 100 bpm; 5) No parenting plan in six months. Female subjects are not pregnant, non-lactating, and can avoid menstruation during the study.
Exclusion criteria
Exclusion criteria: 1) Have serious cardiovascular, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, nervous or mental diseases history, or have these diseases in progress; 2) Have history of clinically significant allergic reactions, especially drug allergies; 3) Positive results in HBsAg, HCV-IgG, HIV1/2-IgM or TPHA-IgM tests; 4) Have history of clinically significant abnormal ECG; 5) Clinically significant abnormal ECG or Cardiac Electrophysiology parameters; 6) Clinically significant abnormal results in laboratory tests. Endogenous creatinine clearance rate is less than 100 mL/min, and the CCr is calculated following the Cockcroft-Gault formula: CCr (ml/min)=(male)(140-age)×weight (kg)/72=Serum creatinine(mg/dL)CCr(ml/min)=(female)(140-age)×weight (kg)/85=Serum creatinine(mg/dL). Serum potassium is below the lower limit of the normal range; 7) Pregnant women (pregnancy test is positive), lactating women. Have parenting plan in six months for both male and female subjects; 8) Have serious diseases in the last 2 weeks before the study; 9) Take any trial drug in the last 3 months before the study; 10) Have any OTC drug in the last 3 weeks, or prescription drug in the last 1 month before the study; 11) Blood donation over 200 mL in the last 3 months. Have plan to donate blood or blood components within 1 month after the study; 12) Drug abusers or alcohol abusers; 13) Heavy smokers (over 5 cigarettes per day). Mild smokers (no more than 5 cigarettes per day) should stop smoking from day -1, and smoking is forbidden during the study; 14) Subjects with hemophobia, or subjects fainting during acupuncture; 15) The subjects researchers consider are not suitable for the clinical trial, or will not complete the trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance;Adverse event; | — |
Countries
China
Contacts
Public ContactLIN Yang
Beijing Jialin Pharmaceutical Co.,Ltd.
Outcome results
None listed