Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06864793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: