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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch.
Take fluconazole on an empty stomach
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Jinan, Shandong, China
Cmax
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Time frame: From Day1 to Day50
AUC0-t
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Time frame: From Day1 to Day50
AUC0-∞
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Time frame: From Day1 to Day50
%AUCex
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Time frame: From Day1 to Day50
Tmax
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Time frame: From Day1 to Day50
t1/2
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Time frame: From Day1 to Day50
Adverse event
Frequency, type and severity of adverse events/serious adverse events.
Time frame: From Day1 to Day50
ECG(Electrocardiogram)
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Take efavirenz on an empty stomach
Evaluation parameters include heart rate, PR interval, QTcF and QRS interval, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day50
Body temperature
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day50
Blood pressure
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day50
Pulse
Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day50