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A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects

NCT05369858 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-05-11

No results posted yet for this study

Summary

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] SKLB1028.

Conditions

  • Healthy Male Subjects

Interventions

DRUG

[14C] SKLB1028

A single 150 mg oral dose of \[14C\] SKLB1028 containing approximately 120 microcurie of \[14C\] SKLB1028

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2021-09-04
Completion
2021-09-11

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 NCT05369858 on ClinicalTrials.gov