NCT07492173

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, randomized, open-label, two-drug, single-dose, four-cycle, crossover study aimed at evaluating the bioequivalence of the test formulation versus the reference formulation, trifluorouracil tepiazole tablets (20mg), in Chinese patients with solid tumors. The planned blood sampling time points: 0h (within 1 hour before administration) and 20 minutes, 40 minutes, 1 hour, 1 hour 20 minutes, 1 hour 40 minutes, 2 hours, 2 hours 20 minutes, 2 hours 40 minutes, 3 hours, 3 hours 20 minutes, 3 hours 40 minutes, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, a total of 19 points. Blood sampling time points after the meal: 0h (within 1 hour before administration) and 30 minutes, 1 hour, 1 hour 20 minutes, 1 hour 40 minutes, 2 hours, 2 hours 20 minutes, 2 hours 40 minutes, 3 hours, 3 hours 20 minutes, 3 hours 40 minutes, 4 hours, 4.5 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, a total of 19 points.

Conditions

• Solid Tumor Cancer

Interventions

Type	Name	Description
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), batch number: 304220201, manufacturing date: February 23, 2022, tentative expiry date: January 2024; Manufactured by Shandong New Time Pharmaceutical Co., Ltd. Three tablets each time.
DRUG	Lonsurf®	Trifluridine and Tipiracil Tablets, strength: 20 mg (expressed as Trifluridine), batch number: 0K71, manufacturing date: November 2, 2020, expiry date: November 1, 2023; Manufactured by Taiho Pharmaceutical Co., Ltd. Kitajima Plant. Three tablets each time.

Timeline

• Start date: 2022-11-21
• Primary completion: 2023-06-25
• Completion: 2023-06-25
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China