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A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Dolutegravir Sodium Tablets (DTG)

NCT07002229 · 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 FNC and Dolutegravir Sodium Tablets in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 5 consecutive days each cycle, and the washout period between each cycle was 7 days. Biological sample collection and safety examination were performed.

Conditions

  • Healthy

Interventions

DRUG

Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)

This study consisted of 3 cycles, each cycle was administered orally for 5 consecutive days, and the washout period between each cycle was 7 days. Subjects were administered the drug as follow: FNC+ DTG: FNC 3 mg (1 tablet) + DTG 50 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 5 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days; DTG: 50 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days.

DRUG

Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)

This study consisted of 3 cycles, each cycle was administered orally for 5 consecutive days, and the washout period between each cycle was 7 days. Subjects were administered the drug as follow: FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days; DTG: 50 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days; FNC+ DTG: FNC 3 mg (1 tablet) + DTG 50 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 5 consecutive days.

DRUG

Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)

This study consisted of 3 cycles, each cycle was administered orally for 5 consecutive days, and the washout period between each cycle was 7 days. Subjects were administered the drug as follow: DTG: 50 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days; FNC+ DTG: FNC 3 mg (1 tablet) + DTG 50 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 5 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 5 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
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2022-02-23
Completion
2022-09-09

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 NCT07002229 on ClinicalTrials.gov