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A Bioequivalence Study of Capecitabine Tablets

NCT01846650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-10-01

No results posted yet for this study

Summary

1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)
2. Experimental Design： Two-period crossover design
3. Test drug: Capecitabine tablets Reference drug: XELODA
4. Sample size：24

Conditions

  • Metastatic Breast Cancer or Metastatic Colorectal Cancer

Interventions

DRUG

Capecitabine tablets

Single oral Capecitabine tablets 2000mg qd

DRUG

XELODA

Single oral XELODA 2000mg qd

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wen Ai dong, doctor · First Affiliated Hospital of Fourth Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

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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 NCT01846650 on ClinicalTrials.gov