A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorSuzhou Centergene Pharmaceuticals Co.,Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Healthy female subjects aged 20 to 40 years old (including boundary values).
Weight not less than 45.0 kg, body mass index within the range of 19.0~26.0 kg/m2 (including boundary values).
Menstrual cycle regularity, or menstrual regularity before taking oral contraceptives (25-34 days, including boundary values).
The levels of follicle stimulating hormone(FSH), luteinizing hormone(LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T) detected within 2-3 days after the last menstrual period before the first administration are within normal ranges or considered abnormal by the researchers to have no clinical significance.
Disqualifiers
Allergy or suspected allergy to any component of the experimental drug, control drug, GnRH, GnRH analogs used in this study.
Use of any LH preparation, human menopausal gonadotropin (hMG) or human chorionic gonadotropin (hCG) preparation within 3 months prior to screening.
Previously or currently suffering from the following diseases: hypothalamic or pituitary tumors, unexplained ovarian enlargement or cyst, Abnormal uterine bleeding of unknown etiology, malignant tumors of the ovaries, uterus, or breast, active thromboembolic diseases, uncontrollable thyroid or adrenal dysfunction, endocrine disorders such as hyperprolactinemia, polycystic ovary syndrome, ovarian hyperstimulation syndrome (OHSS), and ovarian dysfunction, other malignant tumors or diseases of the hypothalamus, pituitary gland, ovaries, and uterus (excluding uterine fibroids).
Ectopic pregnancy within 3 months prior to screening.
Trial design
Treatments tested in this trial
- T-R (Test-Reference drug)
- R-T (Reference-Test drug)
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov