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NOT YET RECRUITING
NCT07341672
PHASE1

A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.

Official title: The Drug-Drug Interaction Study of Clifutinib

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03-04

Completion Date

2026-05-08

Last Updated

2026-01-14

Healthy Volunteers

Yes

Interventions

DRUG

Clifutinib

The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.

DRUG

Itraconazole

Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch.

DRUG

fluconazole

Take fluconazole on an empty stomach

DRUG

efavirenz

Take efavirenz on an empty stomach

Locations (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)

Jinan, Shandong, China