Cardiac arrhythmia
Conditions
Interventions
C:Single dose of Propafenone hydrochloride tablet
A:Single dose of Propafenone hydrochloride Sustained
B:Singly high dose of Propafenone hydrochloride Sust
D:Multiple dose of Propafenone hydrochloride Sustain
E:Multiple dose of Propafenone hydrochloride Sustain
Sponsors
Shandong Lukang Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteer, half male and half female; 2. Age: 18-40 years old, the age difference within the same batch of subjects no more than 10 years old; 3. Weight:the weight of all subjects must be greater than 50 kg with BMI between 19 and 24 kg/m2 (BMI = weight (kg)/height (m2))including the boundary values; 4. Physical and laboratory examination showed normality of various systems and vital signs; 5. According to GCP regulations, subgects obtain informed consent and are voluntarily subjected.
Exclusion criteria
Exclusion criteria: (1) People with primary disease of the heart, liver, kidney and other vital organs, history of gastrointestinal disease, history of metabolic disease,neurological diseases, endocrine system diseases or history of lung disease, hematological diseases, immunological diseases, psychiatry disease; (2) Mental or physical disabilities; (3) People whose physical and chemical examination (blood routine, urine routine, blood biochemistry, ultrasound, chest fluoroscopy, ECG) results revealed abnormality of clinically diagnostic significance within 1 week before the test; (4) People with history of drug dependence, drug abuse or alcoholism; (5) People who are explicitly allergic to the product or its formulation ingredient; (6) People used a certain drugs that has some damages to a certain organs within 3 months; (7) Peole with abnormal vital signs (Systolic blood pressure lower than 90mmHg or 140 mmHg, diastolic blood pressure lower than 50 mmHg or higher than 90 mmHg; heart rate less than 50 bpm or more than 100 bpm); (8) People who were regular drinkers within 6months before the test, drinking more than 14 units alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); people who sucked more than 1 cigarette per day within 3 months before the test; (9) People who took soft drugs such as marijuana within 3 months before the test or hard drugs such as cocaine, phencyclidine and so on within 1 year before the test; (10) There are some factors that may affect drug absorption, distribution, excretion and metabolic; (11) Exclusion of pregnancy, lactation, menstrual period women; (12) People who donated blood within 3 months before the test; (13) The driver and machine gunner; (14) People who are unsuitable for the test such as infirmity according to the judgment of researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Propafenone concentratio; | — |
Countries
Tianjin
Contacts
Public ContactYuhong Huang
Outcome results
None listed