Bioequivalence study in Metastatic Colorectal Cancer Patients

Intervention1: 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil Tablet.: Manufactured by NATCO Pharma Ltd. orally twice daily with approximately 240 mL (8 fluid ounces) of water at ambient temperature after an overnight fast of at least 10 hours Prior to morning dosing and fasting of at least 02 hours prior to evening dosing (except the standard test meal administered 30 minutes prior to dosing) within 30 minutes of completion of morning and evening meals on Cycle 1 (Days 1 through 5) OR Cycle 1 (Day 8 through 12) or Cycle 2 (Days 1 through 5) based on the randomization Schedule.
Control Intervention1: LONSURF Tablet; 35 mg/m2 of Trifluridine; Tipiracil Tablet(15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil tablet ): Manufactured by Taiho Pharmaceutical Co., Ltd., Japan. Manufactured for Taiho Oncology, Inc. Princeton, NJ 08540 USA. orally twice daily with approximately 240 mL (8 fluid ounces) of water at ambient temperature after an overnight fast of at least 10 hours Prior to morning dosing and fasting of at least 02 hours prior to evening dosing (except the standard test meal administered 30 minutes prior to dosing) within 30 minutes of completion of morning and evening meals on Cycle 1 (Days 1 through 5) OR Cycle 1 (Day 8 through 12) or Cycle 2 (Days 1 through 5) based on the randomization Schedule
Primary outcome(s): To assess relative bioavailability of 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil Tablet, compared to LONSURF (15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil) Tablet, following multiple dose in Metastatic colorectal cancer patients who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy.Timepoint: 33 Days