Drug-drug Interaction Between Simvastatin and SHR3824

Type 2 Diabetes Clinical Trial

Official title:

Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03329118
• Other study ID #: SHR3824-111
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 30, 2017
• Last updated: November 7, 2017
• Start date: November 24, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: October 2017
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Haiyan Liu, PhD
• Phone: +86-15705155025
• Email: liuhaiyan[@]shhrp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 8, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	The number of volunteers with adverse events as a measure of safety and tolerability.		up to day 15