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Study identifier: NCT07001436 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects

Condition: Renal Insufficiency  ·  Sponsor: Henan Genuine Biotech Co., Ltd.

PhasePhase 1
Planned participants40
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersYes

About this study

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. This trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.

This description comes directly from the study's public registry record.

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Locations (1)

Beijing Jishuitan HospitalBeijing, Beijing Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07001436