Drug-drug Interaction Between Simvastatin and SHR3824
Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes
Started Nov 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedStudy Start
First participant enrolled
November 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2017
CompletedNovember 9, 2017
October 1, 2017
10 days
October 30, 2017
November 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
SHR3824 1Omg,Simavastatin 40mg
EXPERIMENTALtwo 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 1, 2017
Study Start
November 24, 2017
Primary Completion
December 4, 2017
Study Completion
December 8, 2017
Last Updated
November 9, 2017
Record last verified: 2017-10