Clinical trialPhase 1Unknown
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.
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 7 July 2020
- Listed end
- March 2021
- Enrollment
- 48 participants
- Sites
- 1
- Primary outcomes
- Cmax; AUC0-t; AUC0-∞; Tmax; t1/2
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 22 July 2020
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Brief summary public domain (ClinicalTrials.gov)
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
Detailed description public domain (ClinicalTrials.gov)
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.