Clinical Trial: Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans

U.S., March 26 -- ClinicalTrials.gov registry received information related to the study (NCT07492173) titled 'Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans' on March 19.

Brief Summary: The test formulation of Trifluridine and Tipiracil Tablets (20 mg) is bioequivalent to the reference formulation (Lonsurf(R)) in Chinese patients with solid tumors under fed and fasting conditions.

Study Start Date: Nov. 21, 2022

Study Type: INTERVENTIONAL

Condition: Solid Tumor Cancer

Intervention: DRUG: Trifluridine and Tipiracil Tablets

strength: Trifluridine 20 mg, Tipiracil Hydrochloride 9.420 mg (equivalent to Tipiracil 8.19 mg) (strength abbreviated as 20 mg expressed as Trifluridine), bat...