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A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects

NCT06991634 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-17

No results posted yet for this study

Summary

Azvudine (FNC), a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase (RdRp). This is an open, parallel design clinical study to evaluate the pharmacokinetics and safety of Azvudine tablets in healthy adult and elderly subjects in single and multiple doses. The study is divided into two stages. In the first stage, after a single oral administration of 5 mg of Azvudine tablets, biological sample collection and safety examination were performed. After completing the first phase of the test, the subjects can enter the second phase of the test after a 3-day washout period, and received oral administration of 5 mg Azvudine tablets once a day for 7 consecutive days, biological samples were collected and safety tests were performed.

Conditions

  • Healthy

Interventions

DRUG

Azvudine tablets

Phase I: oral administration of 5 mg of Azvudine tablets on an empty stomach, single dose, 5 mg per dose. Phase II: oral administration of 5 mg of Azvudine tablets once a day on an empty stomach, 5 mg once a day, for 7 consecutive days.

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-08
Primary Completion
2023-04-27
Completion
2023-06-20

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 NCT06991634 on ClinicalTrials.gov