NCT03975205

To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames

A Bio Equivalence Study of DOXIL and Doxorubicin in Subjects With Lymphoma, Leukemia and Carcinoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Sutphin Drugs · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma Leukemia

Interventions

Type	Name	Description
DRUG	Doxorubicin	To measure bioavailabity of Doxil versus Doxorubicin

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-10-31
• Completion: 2019-12-31
• First posted: 2019-06-05
• Last updated: 2019-06-05

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study