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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
48
The First Hospital of Jilin University
Changchun, Jilin, China
Cmax (maximum plasma concentration)
Maxmum observed serum concentration (Cmax) of QL1012D&Gonal-f® in healthy Chinese female subjects.
Time frame: First Period: From pre-dose (0 hour) to 216 hours post-dose on Day 1. Second Period: From pre-dose (0 hour) to 216 hours post-dose on Day 11
AUC (area under the curve)
Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D&Gonal-f® in healthy Chinese female subjects.
Time frame: First Period: From pre-dose (0 hour) to 216 hours post-dose on Day 1. Second Period: From pre-dose (0 hour) to 216 hours post-dose on Day 11
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