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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
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.
Tianjin People's Hospital
Tianjin, China
Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine and Dolutegravir
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 and Dolutegravir
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 and Dolutegravir
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 29.
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