2020-07-07
2020-12
2021-03
48
NCT04482257
CSPC Ouyi Pharmaceutical Co., Ltd.
CSPC Ouyi Pharmaceutical Co., Ltd.
INTERVENTIONAL
Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2020-07-20 | N/A | 2020-07-21 |
2020-07-21 | N/A | 2020-07-22 |
2020-07-22 | N/A | 2020-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: T-R Subjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV | DRUG: Irinotecan Liposome Injection combined with 5-FU/LV
|
EXPERIMENTAL: R-T Subjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV | DRUG: Irinotecan Liposome Injection combined with 5-FU/LV
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Cmax | Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen). | 0 -190 hours |
AUC0-t | The exposure of Total Irinotecan and Free Irinotecan from time (0) to the last quantifiable concentration (t) will be measured for the test product (CSPC) or the reference product (Ipsen). | 0 -190 hours |
AUC0-∞ | The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (∞) will be calculated for the test product (CSPC) or the reference product (Ipsen). | 0 -190 hours |
Tmax | The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen). | 0 -190 hours |
t1/2 | The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen). | 0 -190 hours |
λz | The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen). | 0 -190 hours |
Secondary Outcome Measures | Measure Description | Time Frame |
---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: xuekun Yao Phone Number: 0311-67808678 Email: [email protected] |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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