Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
Status:
COMPLETED
Trial end date:
2024-07-26
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these two injections in healthy subjects. The main questions it aims to answer are:
\[Question 1\] Is there significant difference in the pharmacokinetic profile between the Iron Sucrose Injection (100 mg/5 mL \[calculated by iron\]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the Iron Sucrose Injection (trade name: Venofer, 100 mg/5 mL \[calculated by iron\]) held by AMERICAN REGENT, INC.? \[Question 2\] Is it safe for the healthy subjects to take the test product (100 mg/5 mL \[calculated by iron\]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product held by AMERICAN REGENT, INC.?
Participants will be randomly divided into group I and group II, with equal number of subjects in each group. Each subject will receive only one dose of either the test product or the reference product in each period (two-sequence crossover study).