Drug-drug Interaction Between Simvastatin and SHR3824

Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03329118

Enrollment

Registered

2017-11-01

Start date

2017-11-24

Completion date

2017-12-08

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

SHR3824,simvastatin, drug-drug interaction

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.

Interventions

DRUGSHR3824, 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Contacts

Primary ContactHaiyan Liu, PhD

liuhaiyan@shhrp.com+86-15705155025

Backup ContactJian Chen, Master

zrygcp@126.com+86-13588084969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026