Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622148
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mg5 mL calculated by iron manufactured by Sichuan Huiyu Pharmaceutical Co Ltd and the Iron Sucrose Injection trade name Venofer 100 mg5 mL calculated by iron held by AMERICAN REGENT INC Question 2 Is it safe for the healthy subjects to take the test product 100 mg5 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
Question 1 Is there significant difference in the pharmacokinetic profile between the Iron Sucrose Injection 100 mg5 mL calculated by iron manufactured by Sichuan Huiyu Pharmaceutical Co Ltd and the Iron Sucrose Injection trade name Venofer 100 mg5 mL calculated by iron held by AMERICAN REGENT INC Question 2 Is it safe for the healthy subjects to take the test product 100 mg5 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None