Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
Phase 1
Completed
- Conditions
- Breast Cancer and Ovarian Cancer
- Interventions
- Drug: SPARC-08-038Drug: Ref-08-038
- Registration Number
- NCT03055143
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ref-08-038 SPARC-08-038 - SPARC-08-038 SPARC-08-038 2 mg/ml SPARC-08-038 Ref-08-038 2 mg/ml Ref-08-038 Ref-08-038 -
- Primary Outcome Measures
Name Time Method Maximum measured plasma concentration 336 hours
- Secondary Outcome Measures
Name Time Method The area under the plasma concentration versus time curve from time 0 to infinity 336 hours