Drug-drug Interaction Between Simvastatin and SHR3824

Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers

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 Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: SHR3824, Simvastatin

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Haiyan Liu, PhD; Phone Number: +86-15705155025; Email: liuhaiyan@shhrp.com
• Study Contact Backup: Name: Jian Chen, Master; Phone Number: +86-13588084969; Email: zrygcp@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR3824 1Omg,Simavastatin 40mg; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 24, 2017
• Primary Completion (Anticipated): December 4, 2017
• Study Completion (Anticipated): December 8, 2017

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: SHR3824,simvastatin, drug-drug interaction
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: SHR3824-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No