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RECRUITING
NCT06599528
PHASE1

A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects

Sponsor: Suzhou Centergene Pharmaceuticals Co.,Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-08-12

Completion Date

2026-12-31

Last Updated

2025-02-10

Healthy Volunteers

Yes

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.

Locations (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, China