Clinical trial
A Multicenter, Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Cross-over Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 20mg/10mL of Dr. Reddy's Laboratories Ltd, India, With That of Doxorubicin Hydrochloride Liposome Injection 20 mg/10mL , Manufactured by: Sun Pharmaceutical Ind. Ltd, India; in Ovarian Cancer Patients Whose Disease Has Progressed or Recurred After Platinum Based Chemotherapy and Who Are Already Receiving or Scheduled to Start Therapy With the Reference Listed Drug Under Fasting Condition.
NCT02260544 is registered in ClinicalTrials.gov with Dr. Reddy's Laboratories Limited as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Multicenter, Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Cross-over Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 20mg/10mL of Dr. Reddy's Laboratories Ltd, India, With That of Doxorubicin Hydrochloride Liposome Injection 20 mg/10mL , Manufactured by: Sun Pharmaceutical Ind. Ltd, India; in Ovarian Cancer Patients Whose Disease Has Progressed or Recurred After Platinum Based Chemotherapy and Who Are Already Receiving or Scheduled to Start Therapy With the Reference Listed Drug Under Fasting Condition.
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- July 31, 2014
- Completion date
- August 31, 2015
- Enrollment
- 49 (actual)
- Sites
- 11
Conditions
As the registry lists them; a condition with its own page is linked.
ovarian epithelial cancer recurrent