a phase I, Open-label, Pharmacokinetic Study of Nebivolol Hydrochloride in Healthy Chinese Volunteers

Phase 1

Completed

• Conditions: Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12615000127505
• Lead Sponsor: Fuwai hospital

Brief Summary

none

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-01-29
• Study Start: 2015-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 67

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified