WHO ICTRP trial

Bioequivalence study of Capecitabine tablets 500 mg

CTRI/2018/05/014342 · Clinical Trials Registry India (CTRI) · Recruiting

Key facts

Trial ID CTRI/2018/05/014342
Public title Bioequivalence study of Capecitabine tablets 500 mg
Scientific title An open label, balanced, randomized, two treatment, three sequence, threeperiod, single dose, Semi replicate, cross over, bioequivalence study of Capecitabine tablets 500 mg of Mega Pharma S.A. Chile and Xeloda® (Capecitabine) tablets 500 mg of Roche in metastatic cancer patients under fed…
Primary sponsor Mega Pharma SA
Secondary sponsors Azidus Laboratories Limited
Registry Clinical Trials Registry India (CTRI)
Recruitment status Recruiting
Study type BA/BE
Countries India
Conditions Health Condition 1: null- Metastatic cancer patients
Interventions Intervention1: Capecitabine tablets 500 m: Capecitabine tablets 500 mg of Mega Pharma S.A. Chile Control Intervention1: Xeloda®: Capecitabine tablets 500 mg of Roche
Registration date May 31, 2018
Target size 42
Secondary IDs AZ/BE/04/17/11
Registry page ctri.nic.in

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