Xuanwu Hospital Beijing,Capital Medical University
Beijing, Beijing Municipality, 100053, China
NCT Number: NCT04712838
The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Beijing, Beijing Municipality, 100053, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis.
Time frame: through study completion, an average of 1 month.
The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the time to reach peak plasma concentration of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the time required for the blood concentration of SHR0302 to drop by half.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the clearance of SHR0302 by non-compartmental analysis.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the apparent volume of distribution of SHR0302 by non-compartmental analysis.
Time frame: through study completion, an average of 1 month
laboratory abnormalities (based on hematology, biochemistry, coagulation function, and urinalysis tests), vital sign measurements (include blood pressure, pulse rate, respiratory rate, and body temperature) and 12-Lead electrocardiogram.
Jiangsu HengRui Medicine Co., Ltd.
Industry
Study on the Bioavailability of SHR0302 Tablets With 3 Different Formulations in Healthy Subjects (Single Center, Random, Open, 3 Cycles, 6 Sequences)
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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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