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[Translation] Study on bioequivalence of iron sucrose injection in healthy volunteers
主要目的:本试验旨在研究健康受试者单次静脉注射四川汇宇制药股份有限公司研制、生产的蔗糖铁注射液(5 ml:100 mg铁和1.6 g蔗糖)在健康受试者体内的药代动力学特征;以AMERICAN REGENT, INC.持证的蔗糖铁注射液(Venofer®,100 mg铁/5 ml)为参比制剂,比较两制剂中药动学参数的差异,评价两制剂的人体生物等效性。次要目的:评估受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study aims to study the pharmacokinetic characteristics of a single intravenous injection of iron sucrose injection (5 ml: 100 mg iron and 1.6 g sucrose) developed and produced by Sichuan Huiyu Pharmaceutical Co., Ltd. in healthy subjects; using the iron sucrose injection (Venofer®, 100 mg iron/5 ml) certified by AMERICAN REGENT, INC. as the reference preparation, to compare the differences in pharmacokinetic parameters between the two preparations and evaluate the human bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.
An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation
This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
A Randomized, Open-label, Parallel, Two-treatment, Single-dose Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia Under Fasting Conditions
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anaemia under fasting condition. The main questions it aims to answer are:
[Question 1] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection (trade name: Ferinject®, strength: 10 mL: 500 mg [calculated by iron]) held by Vifor France?
[Question 2] Is it safe for patient to take ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of patients in each group,to receive test product or reference product according to the protocol below.
Dosing on D1: Group T (Test product) Group R (Reference product)
PK blood sample collection
Safety evaluation
100 Clinical Results associated with Sichuan Huiyu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Sichuan Huiyu Pharmaceutical Co., Ltd.
100 Deals associated with Sichuan Huiyu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Sichuan Huiyu Pharmaceutical Co., Ltd.