Spots Global Cancer Trial Database for To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames
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Trial Identification
Brief Title: To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames
Official Title: A Bio Equivalence Study of DOXIL and Doxorubicin in Subjects With Lymphoma, Leukemia and Carcinoma
Study ID: NCT03975205
Conditions
Interventions
Study Description
Brief Summary: Doxil or Doxorubicin to be administered was administered in a dose of 50 mg/m2 as infusion over 15 minutes. Blood samples to be obtained at 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours
Detailed Description: Comparison of AUC in a single dose of Doxorubicin vs single dose of Doxil \[ Time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days) The primary objective of this study is to determine the pharmacokinetic equivalence of Doxorubicin and Doxil as a single dose in patients with carcinomas, lymphomas and leukemia's. The outcome measure will be determined by analyzing the concentration from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (C max)to determine % variability between doxorubicin and Doxil within each patient.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Bharat Cancer Hospital, Surat, Gujarat, India
Contact Details
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