None listed
Conditions
Brief summary
The purpose of this study is to explore the pharmacokinetic property, pharmacogenetic property as well as the safety and tolerance of Nebivolol Hydrochloride in Chinese healthy volunteers and provide important information for phase II study.
Interventions
For single dose study, volunteers will be assigned to 3 treatment groups of Nebivolol Hydrochloride: 5, 15, 30mg. After a 10-hour overnight fast, volunteers will receive a single dose of Nebivolol Hydrochloride oral tablet at approximately 8 a.m. on the following morning with 200mL water.
For repeated dose study, volunteers will received a single dose of Nebivolol Hydrochloride oral tablet 10mg at approximately 8 a.m. for 7 consecutive days.
Physical examinations, routine laboratory test(i.e.
For single dose study, volunteers will be assigned to 3 treatment groups of Nebivolol Hydrochloride: 5, 15, 30mg. After a 10-hour overnight fast, volunteers will receive a single dose of Nebivolol Hydrochloride oral tablet at approximately 8 a.m. on the following morning with 200mL water. For repeated dose study, volunteers will received a single dose of Nebivolol Hydrochloride oral tablet 10mg at approximately 8 a.m. for 7 consecutive days. Physical examinations, routine laboratory test(i.e., serum chemistry. hemotalogy and urinalysis), electrocardiogram, blood pressure and heart rate will be measured,adverse events will be recorded throughout the trial.
Sponsors
Fuwai hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP, heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing) Genotype of CYP2D6 is *1*1(wild) or *10*10(Homozygous mutant)
Exclusion criteria
1. weight less than 50kg, weight index less than 19 or more than 24; 2. low blood pressure history or blood pressur <90/60mmHg; 3. bradycardia, sinus arrest, sinoatrial block, atrioventricular blocker, ectopic rhythm Holter monitoring; 4.disease or disorders in hepatic, renal. respiratory, immune system and nervous system; 5. alcohol or drug abuse; 6.clinical significant allergies to drug, tape or foods; 7.use of prescription or over-the-counter medication including herbal products within 4 week before study initiation; 8.donate blood or participated in other clinical trials within 3 months before enrollment in the study; 9.positive results on HIV and hepatitis types B and C testing; 10.abnormalities in laboratory test( hematology, blood biochemistry, hepatic function and urinalysis)
Outcome results
None listed