A Randomized, Open, Multicenter, Phase IIa Clinical Study on the Early Bactericidal Activity, Safety, Tolerance and Pharmacokinetics of JDB0131 Benzenesulfonate Tablets in Drug Sensitive Pulmonary Tuberculosis Patients
A randomized, open, drug controlled design of experiments was used to evaluate the early bactericidal activity, safety, tolerance and pharmacokinetic characteristics of JDB0131 benzenesulfonate tablet taken orally by drug sensitive pulmonary tuberculosis patients. Five groups are proposed to be set up in this test (JDB0131 benzenesulfonate 100mg BID, JDB0131 benzenesulfonate 200mg QD, JDB0131 benzenesulfonate 200mg BID, anti tuberculosis drug fixed dose composite dosage QD is determined according to the weight of the study participants, and delamanid 100mg BID)
WXWH0131 片在中国健康成年受试者中单次和多次给药的安全性、
耐受性、药代动力学特征及食物影响的 I 期临床研究
主要目的:
评估中国健康成年受试者空腹条件下单次和多次口服 WXWH0131 片
的安全性和耐受性。
次要目的:
1、评估中国健康成年受试者空腹条件下单次和多次口服
WXWH0131 片的药代动力学特征。 2、评估进食对中国健康成年受试者单次口服 WXWH0131 片药代动
力学的影响。
Phase I clinical study of the safety, tolerability, pharmacokinetic characteristics and food effects of WXWH0131 tablets in single and multiple doses in Chinese healthy adult subjects
100 项与 WXWH-0131 相关的专利(医药)