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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT02892370 |
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Date of registration:
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02/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
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Scientific title:
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An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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14 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02892370 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Chen Yu, BS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai Xuhui central hospital |
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Name:
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Chen Yu |
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Address:
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Telephone:
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86-21-54030254 |
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Email:
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Affiliation:
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Name:
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Chengyu Guan, MD |
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Address:
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Telephone:
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86-21-50118402 |
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Email:
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guanchengyu@hrs.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male
- BMI:19-24 kg/m2, weight > 50 kg.
- Age:18-45
Exclusion Criteria:
- History of clinically significant laboratory results or disease.
- History of alcohol or drug abuse.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: SHR0302
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Primary Outcome(s)
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The accumulative excretion rate of SHR0302 and its metabolites in urine and feces
[Time Frame: up to 96 hrs postdose]
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The maximum plasma concentration (Cmax) of SHR0302
[Time Frame: up to 72 hrs postdose]
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The area under the plasma concentration-time curve (AUC) of SHR0302
[Time Frame: up to 72 hrs postdose]
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Secondary Outcome(s)
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The number of volunteers with adverse events as a measure of safety
[Time Frame: up to Day 21]
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Secondary ID(s)
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SHR0302-103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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