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Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

NCT05072028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-01-03

No results posted yet for this study

Summary

This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of \[14C\]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.

Conditions

  • Healthy Male Subjects

Interventions

DRUG

[14C]DBPR108

\[14C\]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2021-11-28
Completion
2021-11-28

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 NCT05072028 on ClinicalTrials.gov