NCT03055143
Completed
Phase 1
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.
ConditionsBreast Cancer and Ovarian Cancer
Overview
- Phase
- Phase 1
- Intervention
- SPARC-08-038
- Conditions
- Breast Cancer and Ovarian Cancer
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Enrollment
- 29
- Primary Endpoint
- Maximum measured plasma concentration
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
- •Subjects who had no evidence of underlying disease
- •Subjects who had signed written consent form
Exclusion Criteria
- •Females who were pregnant, breastfeeding, or are likely to become pregnant
- •Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
- •Subjects deemed uncooperative or noncompliant
- •Smoking or consumption of any nicotine products
Arms & Interventions
SPARC-08-038
2 mg/ml
Intervention: SPARC-08-038
SPARC-08-038
2 mg/ml
Intervention: Ref-08-038
Ref-08-038
Intervention: SPARC-08-038
Ref-08-038
Intervention: Ref-08-038
Outcomes
Primary Outcomes
Maximum measured plasma concentration
Time Frame: 336 hours
Secondary Outcomes
- The area under the plasma concentration versus time curve from time 0 to infinity(336 hours)
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