This is a phase I study to assess the drug-drug interaction of SH-1028 tablets and Itraconazole/Rifampicin tablets. The study also evaluates the pharmacokinetic and tolerability of SH-1028 tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.
A total of 40 evaluable healthy male subjects will be enrolled in this study.The subjects will be divided into two groups, A and B, with 20 people in each group. In the itraconazole study (Group A), patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally. In the rifampicin study (Group B), patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
tablet, oral, 200 mg once daily for day 1 and day 12
capsule, oral, 200 mg twice daily for day 8 to day 14
capsule, oral, 600 mg once daily for day 8 to day 16
the First Affiliated Hospital with Bengbu Medical College
Bengbu, Anhui, China
Cmax
Pharmacokinetics of SH-1028 by assessment of maximum plasma concentration
Time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
AUC(0-last)
Pharmacokinetics of SH-1028 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint
Time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
AUC(0-∞)
Pharmacokinetics of SH-1028 by assessment of area under the concentration time curve from time 0 to infinity
Time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
Incidence of adverse events
Safety and tolerability
Time frame: Up to 10 days after last dose
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