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A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ)

NCT07001501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-03

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 a clinical study to evaluate the Interactions between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 10 consecutive days each cycle, and the washout period between each cycle was 14 days. Biological sample collection and safety examination were performed.

Conditions

  • Healthy

Interventions

DRUG

Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)

This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days.

DRUG

Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)

This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days.

DRUG

Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)

This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days.

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2022-04-25
Completion
2023-03-13

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 NCT07001501 on ClinicalTrials.gov