Progress on Computational Ethology

Ren, Weirong; Yu, Shan; Zhang, Yong Q.

doi:10.1360/tb-2021-0213

Chin. Sci. Bull.

2021

DOI: 10.1360/tb-2021-0213

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Progress on Computational Ethology

Weirong Ren

Shan Yu

Yong Q. Zhang

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2023

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“…This compromised immune status can readily allow infection by a variety of diseases and can cause malignant tumors associated with a high mortality rate 2 . Zidovudine was first approved in 1987 for the treatment of HIV and since then numerous drugs have been developed to fight this global disease, including nucleoside reverse transcriptase inhibitors (NRTIs), non‐nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, fusion enzyme inhibitors, and C‐C chemokine receptor type 5 (CCR5) inhibitors 3,4 . In addition, Shuangtaizhi (the reference preparation used in the present study) was the first fixed‐dose combination of zidovudine and lamivudine, and was approved for the treatment of HIV patients in 1997 5…”

mentioning

confidence: 99%

Bioequivalence and Pharmacokinetics Study of Two Zidovudine/Lamivudine Tablets in Chinese Healthy Volunteers

Huang,

Wang,

Huang

et al. 2023

Clinical Pharm in Drug Dev

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Zidovudine/lamivudine tablets are nucleoside reverse transcriptase inhibitors that are used to treat human immunodeficiency virus. The objective of this study was to investigate the bioequivalence and pharmacokinetics (PKs) of test and reference preparations of zidovudine/lamivudine tablets in healthy Chinese subjects. We designed a randomized, open, single‐center, single‐dose, 2‐crossover experiment with a 7‐day washout period involving 20 healthy subjects. The subjects were given a single dose of the test or reference preparation after fasting overnight for 10 hours. Blood samples were subsequently collected at scheduled time points from 0 hour (preadministration) up to 24 hours postadministration. The plasma concentrations of zidovudine and lamivudine were determined by a validated ultra‐performance liquid chromatography‐tandem mass spectrometry method. Analysis of variance (ANOVA) was used to compare differences in the mean values of key PK parameters between the 2 preparations. Bioequivalence was evaluated by 2 one‐sided t‐tests and 90% confidence intervals (CIs) of the geometric mean ratio (GMR). In total, 19 of the 20 subjects completed the trial. Based on the analysis of PK parameters, the relative bioavailability of zidovudine and lamivudine was 101.1% ± 2.0% and 100.3% ± 1.5%, respectively. ANOVA found no significant difference in primary PK parameters when compared between the 2 formulations, and the 90% CIs of the GMR of the 2 formulations were within the bioequivalence margins of 80%–125%. No serious adverse events occurred. Thus, we confirmed that the 2 preparations were bioequivalent in healthy Chinese volunteers. Our analysis demonstrated that both products showed good tolerance in all subjects.

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confidence: 99%

Bioequivalence and Pharmacokinetics Study of Two Zidovudine/Lamivudine Tablets in Chinese Healthy Volunteers

Huang,

Wang,

Huang

et al. 2023

Clinical Pharm in Drug Dev

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Progress on Computational Ethology

Cited by 1 publication

References 23 publications

Bioequivalence and Pharmacokinetics Study of Two Zidovudine/Lamivudine Tablets in Chinese Healthy Volunteers

Bioequivalence and Pharmacokinetics Study of Two Zidovudine/Lamivudine Tablets in Chinese Healthy Volunteers

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