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Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients

NCT03974594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-04-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2019-07-16
Completion
2019-07-16

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974594 on ClinicalTrials.gov