Actively Recruiting
A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
Led by Suzhou Centergene Pharmaceuticals Co.,Ltd. · Updated on 2025-02-10
48
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy female subjects aged 20 to 40 years old (including boundary values)
- Weight not less than 45.0 kg and body mass index within 19.0 to 26.0 kg/m2 (including boundary values)
- Regular menstrual cycles or regularity before oral contraceptives (25-34 days, including boundary values)
- Hormone levels (FSH, LH, PRL, E2, P, T) within normal ranges or clinically insignificant abnormalities detected 2-3 days after last menstrual period before first administration
- LH levels <5 IU/L and FSH levels <4 IU/L at Day -1
You will not qualify if you...
- Allergy or suspected allergy to components of the study drugs or related hormones
- Use of LH, hMG, or hCG treatments within 3 months prior to screening
- History or current diseases affecting hypothalamus, pituitary, ovaries, uterus, or breast including tumors, cysts, abnormal bleeding, malignant tumors, thromboembolic diseases, thyroid or adrenal dysfunction, endocrine disorders, polycystic ovary syndrome, ovarian hyperstimulation syndrome, ovarian dysfunction, or other malignancies
- Ectopic pregnancy within 3 months prior to screening
- Acute or chronic infections at screening or enrollment
- Localized disease affecting injection site or inability to tolerate injections
- Difficulty with blood collection or history of needle/blood sickness
- Use of prescription medications within 14 days or over-the-counter medications within 7 days prior to screening
- History of serious illness or disease affecting major organ systems making participation unsuitable
- Clinically significant abnormalities in vital signs, labs, ECG, cytology, or ultrasound
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of mental illness, substance abuse, or positive drug screen on admission
- Excessive caffeine consumption in past 3 months
- Excessive alcohol use or inability to abstain during study
- Smoking at least 5 cigarettes per day in past 3 months or inability to stop tobacco use during trial
- Participation in another drug clinical trial within 28 days or medical device trial within 1 month prior to screening
- Blood donation or bleeding over 400 ml within 3 months prior to screening
- Pregnancy, breastfeeding, or unwillingness to use non-drug contraceptive methods during study
- Previous withdrawal from a trial or deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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