Study to evaluate the pharmacokinetics and relative bioavailability of metabolites in healthy Chinese adult males
To evaluate the pharmacokinetic profile and relative bioavailability of the active metabolite ZX-7101 (parent drug) after a single oral administration of 40 mg ZX-7101A for suspension and 40 mg ZX-7101A tablet in healthy Chinese adult male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Test formulation (T) : ZX-7101A dry suspension Specification: 10 mg/ bag Dosage:40 mg (4 bags)、 once
Reference formulation (R): ZX-7101A tablet Specification: 40 mg/ tablet Dosage:40 mg (1 tablet)、 once
West China Second University Hospital, Sichuan University and Children's Hospital Zhejiang University School of Medicine
Chengdu, Sichuan, China
The pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug)
Pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Time frame: From Day1 up to Day 36
The pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug)
Pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Time frame: From Day1 up to Day 36
The pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug)
Pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Time frame: From Day1 up to Day 36
Relative bioavailability of the active metabolite ZX-7101 (parent drug)
Relative bioavailability of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets.
Time frame: From Day1 up to Day 36
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
To evaluate the safety and tolerability of a single oral administration of ZX-7101A dry suspension (40 mg/tablet) in healthy Chinese adult male subjects
Time frame: From Day 1 up to Day 36
Cmax
To evaluate the pharmacokinetic: Cmax of ZX-7101A (prodrug) after a single oral administration of ZX-7101A dry suspension 40 mg and ZX-7101A tablets 40 mg in healthy Chinese adult male subjects
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Time frame: From Day 1 up to Day 36
AUC0-t
To evaluate the pharmacokinetic: AUC0-t of ZX-7101A (prodrug) after a single oral administration of ZX-7101A dry suspension 40 mg and ZX-7101A tablets 40 mg in healthy Chinese adult male subjects
Time frame: From Day 1 up to Day 36
AUC0-inf
To evaluate the pharmacokinetic:AUC0-inf of ZX-7101A (prodrug) after a single oral administration of ZX-7101A dry suspension 40 mg and ZX-7101A tablets 40 mg in healthy Chinese adult male subjects
Time frame: From Day 1 up to Day 36
Evaluation of palatability
The proportion of all subjects who received ZX-7101A dry suspension with a score ≥50 (including not good not bad, good, very good)
Time frame: On Day 1
Tmax
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : Tmax
Time frame: From Day 1 up to Day 36
Vz/F
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : Vz/F
Time frame: From Day 1 up to Day 36
CL/F
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : CL/F
Time frame: From Day 1 up to Day 36
t1/2
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : t1/2
Time frame: From Day 1 up to Day 36
λz
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : λz
Time frame: From Day 1 up to Day 36