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Study on Human Bioequivalence of Triprerelin Acetate for Injection

NCT06683066 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Prostate Cancer (CRPC)

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.

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Shanxi Medical University

    collaborator OTHER

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • First Affiliated Hospital of Chengdu Medical College

    collaborator OTHER

  • Zibo Central Hospital

    collaborator OTHER_GOV

  • Yuncheng Central Hospital

    collaborator OTHER

  • Yichang Central People's Hospital

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2025-09-04
Completion
2025-09-04

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 NCT06683066 on ClinicalTrials.gov