Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599528
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
A Comparing Study Between SJ04 and Ovidrel in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Trial to Compare the Pharmacokinetics Safety and Immunogenicity of SJ04 and Ovidrel in Healthy Female Subjects in China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This is a single-centre randomised open-label single-dose two-cycle double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel in healthy female subjects Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel both administered at a dose of 250 μg once per cycle and cross-administered after a washout period
Detailed Description:
SJ04 is a biosimilar of Ovidrel and is highly similar to Ovidrel The purpose of this study was to evaluate the similarity of pharmacokinetics PK between recombinant human chorionic gonadotropin injection SJ04 and Ovidrel after administration by a single subcutaneous injection in healthy Chinese female subjects
Forty-eight screened healthy female subjects were randomly divided into 2 groups the T-R group and the R-T group with 24 subjects in each group On the morning of the day of administration they received SJ04 injection or Ovidrel single subcutaneous injection according to the randomisation table both at a dose of 250 μg once per cycle and crossed over after a washout period
Forty-eight screened healthy female subjects were randomly divided into 2 groups the T-R group and the R-T group with 24 subjects in each group On the morning of the day of administration they received SJ04 injection or Ovidrel single subcutaneous injection according to the randomisation table both at a dose of 250 μg once per cycle and crossed over after a washout period
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