the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.
The maximum plasma concentration (Cmax) of SHR3824
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
Time frame: At protocol-specified times up to Day 7 and Day 8
The area under the plasma concentration-time curve (AUC) of SHR3824
AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
Time frame: At protocol-specified times up to Day 7 and Day 8
The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .
AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 .
Time frame: At protocol-specified times up to Day 1 and Day 8
The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.
Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin .
Time frame: At protocol-specified times up to Day 1 and Day 8
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: up to day 15
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