None listed
Conditions
Brief summary
The purpose of this study is to explore the pharmacokinetic and pharmacodynamics property of Nifekalant in Chinese healthy volunteers and provide important information for clinical application.
Interventions
Volunteers were assigned to 3 treatment groups of Nifekalant: A/B/C,
For every volunteer, the clinical procedure could be divied into three periods.
Period 1, Day 1, volunteers received Nifekalant D1 mg/Kg through intravenous administration in 5 minutes..
Period 2, Day 2 and Day 3, no interventions
Period 3, Day 4, volunteers received Nifekalant D1 mg/Kg through intravenous administration in 5 minutes, then immediately followed by Nifekalant D2 mg/Kg/h through intravenous infusion by a infusion
Volunteers were assigned to 3 treatment groups of Nifekalant: A/B/C, For every volunteer, the clinical procedure could be divied into three periods. Period 1, Day 1, volunteers received Nifekalant D1 mg/Kg through intravenous administration in 5 minutes.. Period 2, Day 2 and Day 3, no interventions Period 3, Day 4, volunteers received Nifekalant D1 mg/Kg through intravenous administration in 5 minutes, then immediately followed by Nifekalant D2 mg/Kg/h through intravenous infusion by a infusion pump working for 6 hours. For simplicity, we described the whole dose plan as (D1+ D1 mg/Kg + D2 mg/Kg/h) . Group A : 8 volunteers received (0.3+0.3mg/Kg+0.4mg/Kg/h), 4 volunteers received (0.3+0.3mg/Kg/+0.8 mg/Kg/h) Group B : 8 volunteers received (0.4+0.4mg/Kg+0.6mg/Kg/h), 4 volunteers received (0.4+0.4mg/Kg+0.8 mg/Kg/h) Group C : 8 volunteers received (0.5+0.5mg/Kg+0.8mg/Kg/h), 4 volunteers received (0.5+0.5mg/Kg+0.6 mg/Kg/h)
Sponsors
Fuwai hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male Chinese volunteers between the ages of 19-40. Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP and heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing.
Exclusion criteria
1, vital signs abnormal(SBP < 90mmHg or > 140mmHg, DBP < 50mmHg or > 90mmHg, HR < 50 bpm or > bpm). 2, Electrocardiographic abnormality with clinical significance or QTc interval > 400ms. 3, Holter monitor found sinus beat stop, third degree sinoatrial conduction block, atrioventricular block or heterotopic heart rate. 4, clinical significant allergies to drug or foods; 5, alcohol or drug abuse; 6, alcoholics or frequent drinkers 6 months before the study (that is 14 unit of alcohol weekly). 7, heavy smoker or smoking amount more than 5 cigarettes 3 months before the study 8, positive results on HIV and hepatitis types B and C testing 9, donate blood or participated in other clinical trials within 3 months before enrollment in the study.
Outcome results
None listed