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A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects

NCT05208814 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-24

No results posted yet for this study

Summary

To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets after single dose oral administration, so as to provide basis for formulating clinical medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H tablets in patients with renal insufficiency and healthy subjects

Conditions

Interventions

DRUG

TPN171H single dose

10 mg TPN171H taken once

Sponsors & Collaborators

  • Shanghai Institute of Materia Medica, Chinese Academy of Sciences

    collaborator OTHER

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Jia Miao · West China Hospital

  • Ping Fu · West China Hospital

  • Xiaolan Yong · Chengdu Xinhua Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-10-25
Completion
2022-10-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05208814 on ClinicalTrials.gov