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RECRUITING
NCT06683066
PHASE1

Study on Human Bioequivalence of Triprerelin Acetate for Injection

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

To investigate the pharmacokinetics of triprerelin acetate for injection and triprerelin acetate (Dufferin ®) for injection of reference preparation in patients with prostate cancer by single intramusculodynamic injection in fasting state, and to evaluate the bioequivalence of the two formulations in fasting state.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-12-04

Completion Date

2025-09-04

Last Updated

2024-11-12

Healthy Volunteers

No

Interventions

DRUG

Triprorelin for injection

Specification: Triprorelin for injection 3.75mg. Produced and supplied by Qilu Pharmaceutical Co.

DRUG

Diphereline

Specification: Diphereline 3.75mg. Produced by Ipsen Pharma Biotech and supplied by Qilu Pharmaceutical Co.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China