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Drug-drug Interaction Between Simvastatin and SHR3824

NCT ID: NCT03329118

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-24

Study Completion Date

2017-12-08

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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SHR3824,simvastatin, drug-drug interaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SHR3824, Simvastatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Haiyan Liu, PhD

Role: CONTACT

Phone: +86-15705155025

Email: [email protected]

Jian Chen, Master

Role: CONTACT

Phone: +86-13588084969

Email: [email protected]

Other Identifiers

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SHR3824-111

Identifier Type: -

Identifier Source: org_study_id