Drug-drug Interaction Between Simvastatin and SHR3824

Phase 1

• Conditions: Type 2 Diabetes
• Interventions: Drug: SHR3824, Simvastatin

• Registration Number: NCT03329118
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09
• Study Start: 2017-11-24
• Primary Completion: 2017-12-04
• Study Completion: 2017-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR3824 1Omg,Simavastatin 40mg	SHR3824, Simvastatin	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.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SHR3824	At protocol-specified times up to Day 7 and Day 8	Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
The area under the plasma concentration-time curve (AUC) of SHR3824	At protocol-specified times up to Day 7 and Day 8	AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .	At protocol-specified times up to Day 1 and Day 8	AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 .
The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.	At protocol-specified times up to Day 1 and Day 8	Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin .
The number of volunteers with adverse events as a measure of safety and tolerability.	up to day 15