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

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ClinicalTrials.gov Identifier: NCT02353975
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: SHR3824 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: SHR3824
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.

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




Primary Outcome Measures :
  1. The maximum plasma concentration (Cmax) of SHR3824 [ Time Frame: Day 1-4 on visit 2 and visit 3 ]
    Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state

  2. The area under the plasma concentration-time curve (AUC) of SHR3824 [ Time Frame: Day 1-4 on visit 2 and visit 3 ]
    AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state

  3. The accumulative excretion rate of SHR3824 and its metabolites in urine and feces [ Time Frame: Day 1-4 on visit 2 and visit 3 ]
    Accumulative excretion rate will be compared under fating state and fasted state


Secondary Outcome Measures :
  1. The number of volunteers with adverse events as a measure of safety and tolerability. [ Time Frame: Up to Day 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy.
  • BMI 18-25 kg/m2.

Exclusion Criteria:

  • History of clinically significant illness.
  • History of alcohol or drug abuse.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02353975    
Other Study ID Numbers: SHR3824-104
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR3824
food effect
mass
balance
Phase I