NCT03974594

Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients

Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients Under Fasting or Postprandial Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Trifluridine and Tipiracil Tablets is a nucleoside anti-metabolic and anti-cancer compound developed by Taiho (Dapeng) Co., Ltd., Japan, for the treatment of advanced colorectal cancer that inoperable resection, and progressed or relapsed after standard treatment. This study mainly evaluates bioequivalence, safety and tolerance of Trifluridine and Tipiracil Tablets in colorectal cancer patients.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine and Tipiracil Tablets	Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle
DRUG	TAS-102	TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle

Timeline

• Start date: 2019-05-21
• Primary completion: 2019-07-16
• Completion: 2019-07-16
• First posted: 2019-06-05
• Last updated: 2022-04-19

Locations

1 site across 1 country: China