Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT06090123
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
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Notify Me18 year–40 year
Male
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200031, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48 hours after taking TPN171H
Maximum Plasma Concentration (Cmax) of TPN171H
Time frame: 48 hours after taking TPN171H
Area under the plasma concentration versus time curve (AUC) of TPN171H
Time frame: Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :Tmax
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :T1/2
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :CL/F
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :Vz/F
Vigonvita Life Sciences
Industry
A Phase 1,Parallel Assignment,Fixed-Sequence Study to Assess the Effect of Itraconazole, Rifampicin on the Pharmacokinetics of TPN171H in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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