Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingPhase 1 QB0208-1 胶囊在良性前列腺增生症患者中的药代动力学、药效学和安全性的Ⅰ期临床研究
[Translation] Phase I clinical study on the pharmacokinetics, pharmacodynamics and safety of QB0208-1 capsule in patients with benign prostatic hyperplasia
主要目的:评价中国良性前列腺增生症患者口服 QB0208-1 胶囊后的药代动力学特征;
次要目的:评价中国良性前列腺增生症患者口服 QB0208-1 胶囊后的药效学;评价中国良性前列腺增生患者症口服 QB0208-1 胶囊后的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetic characteristics of QB0208-1 capsules after oral administration in Chinese patients with benign prostatic hyperplasia;
Secondary objective: To evaluate the pharmacodynamics of QB0208-1 capsules after oral administration in Chinese patients with benign prostatic hyperplasia; To evaluate the safety of QB0208-1 capsules after oral administration in Chinese patients with benign prostatic hyperplasia.
一项评估QB0208-1在健康受试者中的安全性、耐受性和药代动力学的随机、双盲、安慰剂对照、单次及多次给药剂量递增和食物影响的I期临床试验
[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose escalation and food-effect Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of QB0208-1 in healthy subjects
1、考察健康受试者单、多次口服QB0208-1胶囊的安全性和耐受性。
2、考察健康受试者单、多次口服QB0208-1胶囊的药代动力学(Pharmacokinetics,PK)特征。
3、评价高脂高热量食物对健康受试者单次服用QB0208-1胶囊后PK特征的影响。
[Translation] 1. To investigate the safety and tolerability of single and multiple oral administration of QB0208-1 capsules in healthy subjects.
2. To investigate the pharmacokinetic (PK) characteristics of single and multiple oral administration of QB0208-1 capsules in healthy subjects.
3. To evaluate the effect of high-fat and high-calorie food on the PK characteristics of QB0208-1 capsules in healthy subjects after single administration.
/ Not yet recruitingPhase 1 [14C]QB0208-1 在中国健康受试者中的物质平衡研究
[Translation] [14C]QB0208-1 Material balance study in Chinese healthy subjects
主要目的:
1、定量分析男性健康受试者单次口服[14C]QB0208-1后排泄物中的总放射性,获得人体放射性总回收率、放射性排泄数据和主要排泄途径,获得全血(如适用)和血浆总放射性的药代动力学参数,同时考察全血和血浆中总放射性的分配情况及QB0208-1 进入人体后的绝对生物利用度(Fabs)
2、定量分析男性健康受试者单次口服[14C]QB0208-1后人血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定 QB0208-1 在人体内的代谢途径及消除途径。
次要目的:
1、采用经验证的液相色谱串联质谱法(LC-MS/MS)定量分析血浆中 QB0208-1 及其代谢产物(如适用)的浓度,获得血浆中QB0208-1 及其代谢产物(如适用)的药代动力学参数;
2、观察男性健康受试者单次口服[14C]QB0208-1 后、单 次 口 服 QB0208-1 和 静 脉 滴 注 微 剂 量[14C]QB0208-1 后的安全性
[Translation] Main objectives:
1. Quantitatively analyze the total radioactivity in the excreta of male healthy subjects after a single oral administration of [14C]QB0208-1, obtain the total recovery rate of human radioactivity, radioactivity excretion data and the main excretion pathway, obtain the pharmacokinetic parameters of total radioactivity in whole blood (if applicable) and plasma, and investigate the distribution of total radioactivity in whole blood and plasma and the absolute bioavailability (Fabs) of QB0208-1 after entering the human body
2. Quantitatively analyze the radioactive metabolite spectrum of human plasma, urine and feces after a single oral administration of [14C]QB0208-1 in male healthy subjects, identify the main metabolites, and determine the metabolic pathways and elimination pathways of QB0208-1 in the human body.
Secondary objectives:
1. To quantitatively analyze the concentration of QB0208-1 and its metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and obtain the pharmacokinetic parameters of QB0208-1 and its metabolites (if applicable) in plasma;
2. To observe the safety of male healthy subjects after a single oral administration of [14C]QB0208-1, a single oral administration of QB0208-1, and intravenous infusion of micro-doses of [14C]QB0208-1.
100 Clinical Results associated with Beijing Qingbo Huineng Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Beijing Qingbo Huineng Pharmaceutical Technology Co., Ltd.
100 Deals associated with Beijing Qingbo Huineng Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Beijing Qingbo Huineng Pharmaceutical Technology Co., Ltd.