Breast Cancer
Conditions
Brief summary
Pharmacokinetic, bioequivalence study
Interventions
DRUGSPARC1210
DRUGReference1210
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The subject has given written, informed consent and is available for the entire study. * Histologically or cytologically confirmed diagnosis of breast cancer; * Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option; * Age 18 years or more
Exclusion criteria
* Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol); * Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy; * Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0); * Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed concentration (Cmax) | Pre-dose, post-dose up to 3 days | Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Day 3 | AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0 |
Countries
India
Outcome results
None listed