The purpose of the study is to investigate the potential interaction between SP2086 and Simvastatin after the multiple oral doses treatment in healthy adult volunteers.
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Simvastatin in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences. The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10; Simvastatin will be administered orally (by mouth) as 200mg on Day 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd on Day6-Day10. There were 5 days washout period between A and B. The total time of this trial was 27 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
People's Liberation Army General Hospital of Chengdu Military Region
Chengdu, China
The maximum plasma concentration (Cmax) of SP2086
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
Time frame: up to Day 27
The maximum plasma concentration (Cmax) of SP2086 acid
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
Time frame: up to Day 27
The maximum plasma concentration (Cmax) of Simvastatin
Cmax (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin
Time frame: up to Day 27
The area under the plasma concentration-time curve (AUC) of SP2086
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
Time frame: up to Day 27
The area under the plasma concentration-time curve (AUC) of SP2086 acid
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
Time frame: up to Day 27
The area under the plasma concentration-time curve (AUC) of Simvastatin
AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin
Time frame: up to Day 27
The number of volunteers with adverse events as a measure of safety and tolerability
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Time frame: up to Day 27