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NCT Number: NCT02353975

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

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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Key information

Conditions

Type 2 Diabetes Arachnodactyly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Limb Deformities, Congenital Metabolic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy.
  • BMI 18-25 kg/m2.

Exclusion criteria

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

Treatment and study plan

SHR3824

Drug

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

Primary outcomes

  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 outcomes

  1. The number of volunteers with adverse events as a measure of safety and tolerability.

    Time frame: Up to Day 12

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2015
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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