drugset / Trial / NCT06599528
A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
RandomizedCrossoverOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2024-08-12
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ovidrel | Protein / enzyme biologic | 250 ug | Subcutaneous |
| Subject | SJ04 | Protein / enzyme biologic | 250 ug | Subcutaneous |