Trials / Recruiting
RecruitingNCT06683066
Study on Human Bioequivalence of Triprerelin Acetate for Injection
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- The Affiliated Hospital of Qingdao University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-12-04
- Primary completion
- 2025-09-04
- Completion
- 2025-09-04
- First posted
- 2024-11-12
- Last updated
- 2024-11-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06683066. Inclusion in this directory is not an endorsement.