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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
Tianjin People's Hospital
Tianjin, China
Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine, Lopinavir and Ritonavir
Time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine, Lopinavir and Ritonavir
Time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine, Lopinavir and Ritonavir
Time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Occurrence of Adverse Events
Clinical presentation characteristics, severity, onset time, duration of adverse events, management measures, outcomes, and the correlation with the investigational drug.
Time frame: From enrollment to the end of the study on Day 28.
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