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Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.

Advanced Pancreatic Cancer Clinical Trial

Official title:
*Official Title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.

Clinical Trial Summary

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.

Clinical Trial Description

The purpose of this study was to determine the bioequivalence of two formulations of Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer, under fasting condition. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04482257
Study type Interventional
Source CSPC Ouyi Pharmaceutical Co., Ltd.
Contact xuekun Yao
Phone 0311-67808678
Email yaoxuekun@mail.ecspc.com
Status Recruiting
Phase Phase 1
Start date July 7, 2020
Completion date March 2021
View Details
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