Infertility, Female
Conditions
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.
Interventions
DRUGQL1012D
A single Subcutaneous injection, 225IU
DRUGGonal-F®
A single Subcutaneous injection, 225IU
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, Age between 18 to 45 years (inclusive). * Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg. * With a history of sexual activity * Regular menstruation cycle (25 to 35 days, inclusive). * Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator. * Reached the standard within the time window after receiving the down-regulated drug. * Agreed to take effective contraceptive measures during and 6 months after the end of the study period. * Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.
Exclusion criteria
* History of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; History of thrombosis; or other diseases that considered to influence the study by the investigator. * Unexplained reproductive tract bleeding. * Thin-layer cytology examination deemed clinically significant by the investigator. * Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with. * Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination. * Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs * Consume strong coffee or tea daily * Historic abuse of alcoholic beverages * Smoke ≥5 cigarettes per day within 3 months prior to the study * History of drug abuse * Unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (maximum plasma concentration) | 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 | Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects. |
| AUC (area under the curve) | 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 | Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D＆Gonal-f® in healthy Chinese female subjects. |
Countries
China
Outcome results
None listed