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Clinical trial

Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two- Sequence, Single Dose, Crossover Bioequivalence Study Between Two Formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) [Doxopeg® Manufactured by FAPASA - Farmaceutica Paraguay S.A. and Registered by Adium S.A., Formerly Zodiac Produtos Farmacêuticos S.A, (Test Formulation) and Caelyx® Manufactured by Janssen Pharmaceutica NV (Reference Formulation)] in Patients With Advanced Ovarian Cancer or Metastatic Breast Cancer

NCT07648940 is registered in ClinicalTrials.gov with Zodiac Produtos Farmaceuticos S.A. as lead sponsor.

NCT NCT07648940
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Registry record

As filed in ClinicalTrials.gov.

Title
Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two- Sequence, Single Dose, Crossover Bioequivalence Study Between Two Formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) [Doxopeg® Manufactured by FAPASA - Farmaceutica Paraguay S.A. and Registered by Adium S.A., Formerly Zodiac Produtos Farmacêuticos S.A, (Test Formulation) and Caelyx® Manufactured by Janssen Pharmaceutica NV (Reference Formulation)] in Patients With Advanced Ovarian Cancer or Metastatic Breast Cancer
Lead sponsor
Zodiac Produtos Farmaceuticos S.A.
Phase
Phase 1
Overall status
Completed
Start date
February 13, 2023
Completion date
June 22, 2023
Enrollment
74 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

advanced ovarian cancer, metastatic breast cancer