drugset / Trial / NCT07002229

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

NCT07002229

Phase 1 Completed 15 enrolled Henan Genuine Biotech Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Azvudine Small molecule 3 mg Oral
Subject Dolutegravir Other / unclassified 50 mg Oral

Indications

No indication recorded.