Mass Balance and Biotransformation of [14C]HSK7653 in Human
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|ClinicalTrials.gov Identifier: NCT04540016|
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes||Drug: [14C]HSK7653||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single-center, single-dose, non-randomized, open-label design.|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial on Absorption, Metabolism, and Excretion of [14C]HSK7653 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK7653 in Human|
|Estimated Study Start Date :||October 15, 2020|
|Estimated Primary Completion Date :||December 29, 2020|
|Estimated Study Completion Date :||March 30, 2021|
25 mg of 80 µCi [14C]HSK7653.
25 mg of [14C]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition.
- Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose [ Time Frame: From the start of administration to 50 day after administration ]Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK7653，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).
- Peak concentration (Cmax) [ Time Frame: From the start of administration to 50 day after administration ]Pharmacokinetic Measures
- Area under the concentration-time curve (AUC0-t, AUC0-∞) [ Time Frame: From the start of administration to 50 day after administration ]Pharmacokinetic Measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540016
|Contact: Shiping Ma, PhDfirstname.lastname@example.org|
|Contact: Kai Chen, PhDemail@example.com|
|the First Affilicated Hospital of Soochow University||Recruiting|
|Contact: miao liyan, PhD 0371-66295219|
|Principal Investigator:||Liyan Miao, PhD||Medical Ethics Committee of the First Affiliated Hospital of soochow University|