NCT07002229

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-12-09
• Primary completion: 2022-02-23
• Completion: 2022-09-09
• First posted: 2025-06-03
• Last updated: 2025-06-03

Locations

1 site across 1 country: China