NCT07002242

A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia

• 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 Azvudine Tablets (FNC) and Aluvia 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 Aluvia	FNC 3 mg each time, 1 time a day, orally, for 5 consecutive days. Aluvia(Lopinavir / Ritonavir tablets): 400 mg/100 mg (2 tablets) each time, 2 time a day, orally, for 5 consecutive days.
DRUG	Azvudine tablets(FNC)	FNC: 3 mg each time, 1 time a day, orally, for 5 consecutive days
DRUG	Aluvia	Aluvia(Lopinavir / Ritonavir tablets): 400 mg/100 mg (2 tablets) each time, 2 time a day, orally, for 5 consecutive days.

Timeline

• Start date: 2022-07-06
• Primary completion: 2022-08-25
• Completion: 2023-02-21
• First posted: 2025-06-03
• Last updated: 2025-10-02

Locations

1 site across 1 country: China