Breast Cancer and Ovarian Cancer
Conditions
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.
Interventions
DRUGSPARC-08-038
2 mg/ml intravenous infusion
DRUGRef-08-038
2 mg/ml intravenous infusion
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years. 3. Subjects who had no evidence of underlying disease 4. Subjects who had signed written consent form
Exclusion criteria
1. Females who were pregnant, breastfeeding, or are likely to become pregnant 2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results 3. Subjects deemed uncooperative or noncompliant 4. Smoking or consumption of any nicotine products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum measured plasma concentration | 336 hours |
Secondary
| Measure | Time frame |
|---|---|
| The area under the plasma concentration versus time curve from time 0 to infinity | 336 hours |
Outcome results
None listed