Viewing Study NCT04810533



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Last Modification Date: 2024-10-26 @ 2:00 PM
Study NCT ID: NCT04810533
Status: COMPLETED
Last Update Posted: 2021-03-23
First Post: 2021-03-17

Brief Title: The Absorption Metabolism and Excretion of 14CSH-1028 in Chinese Healthy Male Volunteers
Sponsor: Nanjing Sanhome Pharmaceutical Co Ltd
Organization: Nanjing Sanhome Pharmaceutical Co Ltd

Study Overview

Official Title: A Single-center Open-label Single-dose Phase I Study to Investigate the Absorption Metabolism and Excretion of 14CSH-1028 in Chinese Healthy Male Subjects
Status: COMPLETED
Status Verified Date: 2021-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a single-center open-label single-dose phase I study to investigate the absorption metabolism and excretion of 14C SH-1028 in healthy Chinese male subjects The study will be conducted into two stepsFirstly 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of plasma urine and feces sampling post-dose Then the collection time of blood and excreta samples urine and feces from the subsequent 2-4 subjects will be adjusted according to the pilot study
Detailed Description: Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing D-2 On the morning of Day 1 before dosing subjects will be transferred to nuclear medical ward And after an overnight fast of at least 10 h subjects will receive a single oral dose of 200 mg 88 μCi of 14CSH-1028 as an oral suspension Then after two days of the dosing subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None