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The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers

NCT04810533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-23

No results posted yet for this study

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 steps：Firstly, 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.

Conditions

  • Healthy Male Volunteers

Interventions

DRUG

[14C] SH-1028

Volunteer will receive a single oral dose of 200 mg/88 uCi \[14C\]SH-1028 as a solution on Day 1

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Feng Shao, Ph D · Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

  • Wei Liu, M.A · Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2021-03-05
Completion
2021-03-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810533 on ClinicalTrials.gov