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A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers

NCT05103241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-12-10

No results posted yet for this study

Summary

This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational administration.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C] GP681

40 mg suspension containing 100μCi of \[14C\]GP681

Sponsors & Collaborators

  • Jiangxi Qingfeng Pharmaceutical 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
2021-10-26
Primary Completion
2021-11-22
Completion
2021-11-22

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 NCT05103241 on ClinicalTrials.gov