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Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK21542 in Healthy Adult Male Volunteers.

NCT05835934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-04-28

No results posted yet for this study

Summary

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male subjects.

Conditions

  • Peripheral Analgesic and Anti-itch

Interventions

DRUG

[14C]HSK21542

A single intravenous dose of 2 μg/0.212 μCi/kg \[14C\]HSK21542 in boluses within 2 minute after fasting for at least 10 hours.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Liyan Miao, PhD · Medical Ethics Committee of the First Affiliated Hospital of soochow University

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
2021-06-15
Primary Completion
2021-09-10
Completion
2021-12-20

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 NCT05835934 on ClinicalTrials.gov