NCT04482257

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome Injection combined with 5-FU/LV	Drug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV;

Timeline

• Start date: 2020-07-07
• Primary completion: 2020-12-01
• Completion: 2021-03-01
• First posted: 2020-07-22
• Last updated: 2020-07-22

Locations

1 site across 1 country: China