The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,and assess the effect of itraconazole,cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese healthy male subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Sequence 1:Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6. Sequence 2:Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Sequence 1:Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.
Sequence 2:Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Cmax of TPN171H
Maximum Plasma Concentration (Cmax) of TPN171H
Time frame: 48 hours after taking TPN171H
AUC of TPN171H
Area under the plasma concentration versus time curve (AUC) of TPN171H
Time frame: 48 hours after taking TPN171H
Adverse events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Time frame: Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)
The pharmacokinetic parameters (TPN171H) :Tmax
The pharmacokinetic parameters (TPN171H) :Tmax
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :T1/2
The pharmacokinetic parameters (TPN171H) :T1/2
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :CL/F
The pharmacokinetic parameters (TPN171H) :CL/F
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :Vz/F
The pharmacokinetic parameters (TPN171H) :Vz/F
Time frame: 48 hours after taking TPN171H
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