Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
NCT03055143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2021-07-23
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
- DRUG
-
SPARC-08-038
2 mg/ml intravenous infusion
- DRUG
-
Ref-08-038
2 mg/ml intravenous infusion
Sponsors & Collaborators
-
Sun Pharma Advanced Research Company Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-03
- Primary Completion
- 2009-11-28
- Completion
- 2009-11-28
- FDA Drug
- Yes
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