Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 10, 2018

Primary Completion Date

December 28, 2018

Study Completion Date

January 26, 2019

Conditions
Patient Participation
Interventions
DRUG

150 mg of Xeloda®

Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period. 150 mg of Xeloda® produced by Genentech USA, Inc., a subsidiary of the company, was used as the reference intervention in this study.The subjects randomly received single oral administration of 150 mg of Xeloda®.

DRUG

150 mg of capecitabine

Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period.The tablet of 150 mg of capecitabine from Qilu Pharmaceutical Co., Ltd. (17H0053DE4, Jinan, Shandong Province, China) was used as the test formulation.The subjects randomly received single oral administration of 150 mg of capecitabine.

Trial Locations (1)

266003

Phase Ⅰ Clinical Research Center, Qingdao

All Listed Sponsors
lead

The Affiliated Hospital of Qingdao University

OTHER

NCT04420871 - Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer | Biotech Hunter | Biotech Hunter