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The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers

NCT02356224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-02-05

No results posted yet for this study

Summary

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.

Conditions

Interventions

DRUG

SHR3824

A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.

DRUG

Placebo

A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356224 on ClinicalTrials.gov