Trials / Completed
CompletedNCT05567601
Doxil/Caelyx BE Study
A Randomized, Multi-center, Cross-over, Comparative Bioavailability Study of DOXIL/CAELYX Manufactured at a New Site in Patients With Advanced or Refractory Ovarian or Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Baxter Healthcare Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DOXIL/CAELYX | 40 mg/m2 as a 90-minute IV infusion via a central venous catheter or peripheral vein |
Timeline
- Start date
- 2023-12-16
- Primary completion
- 2024-06-21
- Completion
- 2024-06-21
- First posted
- 2022-10-05
- Last updated
- 2025-06-05
Locations
14 sites across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05567601. Inclusion in this directory is not an endorsement.