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Drug-drug Interaction Between Simvastatin and SHR3824

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329118
Recruitment Status : Unknown
Verified October 2017 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: SHR3824, Simvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers
Estimated Study Start Date : November 24, 2017
Estimated Primary Completion Date : December 4, 2017
Estimated Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Simvastatin

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.




Primary Outcome Measures :
  1. The maximum plasma concentration (Cmax) of SHR3824 [ Time Frame: 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 .

  2. The area under the plasma concentration-time curve (AUC) of SHR3824 [ Time Frame: 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 .

  3. The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid . [ Time Frame: 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 .

  4. The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid. [ Time Frame: 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 .

  5. The number of volunteers with adverse events as a measure of safety and tolerability. [ Time Frame: up to day 15 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329118


Contacts
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Contact: Haiyan Liu, PhD +86-15705155025 liuhaiyan@shhrp.com
Contact: Jian Chen, Master +86-13588084969 zrygcp@126.com

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03329118    
Other Study ID Numbers: SHR3824-111
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR3824,simvastatin, drug-drug interaction
Additional relevant MeSH terms:
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Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors