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 Itraconazole Capsules (ICZ) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 10 consecutive days each cycle, and the washout period between each cycle was 14 days. Biological sample collection and safety examination were performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days.
This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days.
This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days.
Phase I Clinical Trial Research Center of Dongguan Kanghua Hospital
Guangdong, China
Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine and Itraconazole
Time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine and Itraconazole
Time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine and Itraconazole
Time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 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 59.
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