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A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects

NCT06599528 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Assisted Reproductive Technology
  • Female Infertility

Interventions

DRUG

T-R (Test-Reference drug)

T: SJ04 (Test drug) R: Ovidrel® (Referecne drug) 250 μg of SJ04 injection or Oviderl®, administered subcutaneously once at two week intervals.

DRUG

R-T (Reference-Test drug)

R: Ovidrel®(Referecne drug) T: SJ04 (Test drug) 250 μg of SJ04 or Oviderl®, administered subcutaneously once at two week intervals.

Sponsors & Collaborators

  • Suzhou Centergene Pharmaceuticals Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06599528 on ClinicalTrials.gov