RecruitingPhase 1NCT06683066

Study on Human Bioequivalence of Triprerelin Acetate for Injection


Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

120 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether two versions of a hormone-suppressing injection called triptorelin acetate are equivalent in how the body absorbs and processes them (bioequivalence study), in men with prostate cancer who need hormone therapy to lower testosterone. **You may be eligible if...** - You are a male aged 18 or older, weighing at least 50 kg, with a BMI between 19 and 30 - You have prostate cancer confirmed by pathology and are suitable for hormone therapy (androgen deprivation therapy) - You are either new to GnRH-analog treatment, currently receiving stable triptorelin injections, or have previously received GnRH-analog therapy and are suitable to restart - You are in reasonable physical health (ECOG 0–2) **You may NOT be eligible if...** - You have severe organ failure or serious medical conditions - Your prostate cancer is not suitable for hormone treatment - You are unwilling to comply with study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTriprorelin for injection

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

DRUGDiphereline

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

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NCT06683066


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