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A comparative study of Capecitabine Capsules 500 mg and Capecitabine tablet 500 mg in patients of breast, colon or rectal cancer


ABSTRACT: Intervention1: Capecitabine Extended Release Capsules 500 mg of Intas Pharmaceuticals Limited, India: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week Control Intervention1: Capecitabine film coated tablets 500 mg of Accord healthcare Inc, USA: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week Primary outcome(s): To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsors formulation- Capecitabine Extended Release Capsules 500 mg (Test drug, Intas Pharmaceuticals Ltd., India) with Capecitabine) film coated Tablets 500 mg (Reference drug, Intas Pharmaceuticals Ltd., IndiaTimepoint: Pre-dose (Day01, Day 05 to Day 07 and Day 08 Day 12 to Day 14) Post-dose on Day 07 and Day 14

DISEASE(S): Malignant Neoplasm Of Breast Of Unspecified Site

PROVIDER: 2582199 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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