Drug-drug Interaction Between Simvastatin and SHR3824

Study Overview
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Brief Summary
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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.

Official Title
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Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SHR3824, Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2 Exclusion Criteria: History of hypoglycemia History of urinary tract infections,or genital infections History of current clinically significant medical illness as determined by the Investigator Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR3824 1Omg,Simavastatin 40mg<br>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. | Drug: SHR3824, Simvastatin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 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 . | 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 . | 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 . | 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. |  | up to day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR3824,simvastatin, drug-drug interaction