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Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects

NCT ID: NCT02353975

Last Updated: 2015-02-03

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR3824 10mg fasted to fed

SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3.

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.

SHR3824 10mg fed to fasted

SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3.

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.

Interventions

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SHR3824

SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy.
* BMI 18-25 kg/m2.

Exclusion Criteria

* History of clinically significant illness.
* History of alcohol or drug abuse.
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

Other Identifiers

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SHR3824-104

Identifier Type: -

Identifier Source: org_study_id

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