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[14C] PG-011在中国健康成年男性受试者中的物质平衡研究
[Translation] [14C] PG-011 substance balance study in healthy Chinese adult male subjects
主要目的
(1)定量分析健康男性受试者静脉给予[14C] PG-011后排泄物中的总放射性,获得人体放射性回收率和主要排泄途径;
(2)考察健康男性受试者静脉注射[14C] PG-011后全血与血浆总放射性的分配比,以及全血(如适用)和血浆中总放射性的药代动力学特征;
(3)获得健康男性受试者静脉给予[14C] PG-011后血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定主要生物转化途径。
次要目的
(1)定量分析血浆中[14C] PG-011(如适用)、PG-011及其主要代谢产物(如适用)的浓度,获得血浆中[14C] PG-011(如适用)、PG-011及其主要代谢产物(如适用)的药代动力学参数,并获得PG-011鼻喷给药的绝对生物利用度(F);
(2)观察中国健康成年男性受试者鼻喷雾剂给予PG-011及静脉给予[14C] PG-011后的安全性。
[Translation] Main objectives
(1) To quantitatively analyze the total radioactivity in the excreta after intravenous administration of [14C]PG-011 in healthy male subjects, and to obtain the recovery rate of radioactivity in humans and the main excretion pathway;
(2) To investigate the distribution ratio of total radioactivity in whole blood and plasma after intravenous administration of [14C]PG-011 in healthy male subjects, as well as the pharmacokinetic characteristics of total radioactivity in whole blood (if applicable) and plasma;
(3) To obtain the radioactive metabolite profiles in plasma, urine, and feces of healthy male subjects after intravenous administration of [14C]PG-011, to identify the main metabolites, and to determine the main biotransformation pathways. Secondary objectives: (1) To quantitatively analyze the concentrations of [14C]PG-011 (if applicable), PG-011 and its major metabolites (if applicable) in plasma, obtain the pharmacokinetic parameters of [14C]PG-011 (if applicable), PG-011 and its major metabolites (if applicable) in plasma, and obtain the absolute bioavailability (F) of PG-011 after nasal spray administration; (2) To observe the safety of PG-011 after nasal spray administration and intravenous administration in healthy Chinese adult male subjects.
A Single-center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PG-033 by Single Dose Administration and Food Effect in Healthy Volunteers
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of single ascending oral doses(SAD) of PG-033 by directly comparing it with placebo. Meanwhile, the impact of a high-fat meal on the pharmacokinetics of PG-033 will also be evaluated. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body,as well as investigate the effect of PG-033 on the QTc interval.
/ Not yet recruitingPhase 1 [14C] Mass Balance Study of PG-011 in Chinese Healthy Adult Male Participants
100 Clinical Results associated with Beijing Puqi Pharmaceutical Technology Co Ltd.
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