Ovarian Carcinoma
Conditions
Keywords
Carcinoma, Ovary, Carcinoma Ovary
Brief summary
Bioequivalence study of SPARC147609
Interventions
DRUGSPARC147609
IV infusion
DRUGReference147609
IV infusion
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects meeting all of the following criteria will be considered for enrollment in the study: * Availability of subject for the entire study period and willingness to adhere to protocol requirements. * Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given). * Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study. * Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance. * Informed consent form given in written form.
Exclusion criteria
* History or presence of significant: * Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc. * Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. * Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg. * Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study. * Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study. * Participation in another clinical trial within the preceding 90 days of study start * Subjects who have: * Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg * Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg * Pulse rate below 60/min. or above 100/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product | 2 cycles |
Secondary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events | 2 cycles |
Countries
India
Outcome results
None listed