Trials / Completed
CompletedNCT06098599
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
A Multicenter, Randomized, Open-lable, Single-dose, Two-cycle, Double-cross Bioequivalence Study Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Luye Pharma Group Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxorubicin hydrochloride liposome injection | Doxorubicin hydrochloride liposome injection was administered intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial. Doxorubicin hydrochloride liposome injection was diluted with 250mL 5% glucose injection. |
Timeline
- Start date
- 2022-05-17
- Primary completion
- 2023-02-09
- Completion
- 2023-02-09
- First posted
- 2023-10-24
- Last updated
- 2023-10-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06098599. Inclusion in this directory is not an endorsement.