NCT03055143

Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer

A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.

Conditions

• Breast Cancer and Ovarian Cancer

Interventions

Type	Name	Description
DRUG	SPARC-08-038	2 mg/ml intravenous infusion
DRUG	Ref-08-038	2 mg/ml intravenous infusion

Timeline

• Start date: 2008-09-03
• Primary completion: 2009-11-28
• Completion: 2009-11-28
• First posted: 2017-02-16
• Last updated: 2021-07-23

Regulatory

• FDA-regulated drug study