This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.
\[Pharmacokinetic Assessments\] : Blood concentration of atorvastatin, 2-OH atorvastatin * Primary outcome: AUCτ, Css,max of atorvastatin * Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio \[Sefety Assessments\] : Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Samsung Medical Center
Seoul, South Korea
AUCτ of atorvastatin
Area under the plasma drug concentration-time curve at steady state
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Css,max of atorvastatin
Maximum concentration of drug in plasma of atorvastatin at steady state
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Tss,max of atorvastatin
Time to Cmax at steady state
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
AUCτ of 2-OH atorvastatin
Area under the plasma drug concentration-time curve at steady state
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Css,max of 2-OH atorvastatin
Maximum concentration of drug in plasma of 2-OH atorvastatin at steady state
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
metabolic ratio
AUCτ of 2-OH atorvastatin / AUCτ of atorvastatin
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
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