2014 JAN 27 (NewsRx) -- By a News Reporter-Staff News Editor at AIDS Weekly -- Researchers detail new data in Immune System Diseases and Conditions. According to news reporting out of Shanghai, People's Republic of China, by NewsRx editors, research stated, "Tenofovir disoproxil fumarate (TDF) has been approved worldwide for the treatment of adults with chronic hepatitis B and, in combination with other antiretroviral agents, HIV-1 infection. Although its use for the treatment of HIV has been approved by the Chinese State Food and Drug Administration, there are no data on the pharmacokinetic profile of TDF in Chinese individuals."
Our news journalists obtained a quote from the research from GlaxoSmithKline, "This study aimed to investigate the pharmacokinetic properties and tolerability of TDF in healthy Chinese subjects. This open-label, single- and multiple-dose study was conducted in healthy Chinese volunteers. Subjects received TDF 300 mg once daily, administered as a single dose (day 1) and multiple doses (days 4-10). Multiple plasma samples were collected over time, and the concentrations of TDF were determined using LC-MS/MS. Pharmacokinetic parameters were estimated using a noncompartmental model. Tolerability was determined using clinical evaluation and monitoring of adverse events (AEs). Fourteen volunteers were enrolled (7 men, 7 women; mean age, 24.6 years). TDF was rapidly absorbed; median T-max was 0.75 hour, and t(1/2) was similar to 21 hours with single dosing. The mean ratio of AUC(0-tau) steady state/AUC(0-24) single dose was 1.55. The pharmacokinetic properties of TDF were consistent between the single dose and multiple doses, and between men and women. No serious AEs were reported, and there were no discontinuations due to AEs. There was an accumulation of approximately 55% in tenofovir exposure in healthy Chinese between multiple dose and single dose. TDF exhibited a pharmacokinetic profile similar to that of healthy Western subjects in a historical comparison."
According to the news editors, the research concluded: "TDF was generally well tolerated in these healthy Chinese subjects."
For more information on this research see: Pharmacokinetics and Tolerability of Tenofovir Disoproxil Fumarate 300 mg Once Daily: An Open-Label, Single- and Multiple-Dose Study in Healthy Chinese Subjects. Clinical Therapeutics, 2013;35(12):1884-1889. Clinical Therapeutics can be contacted at: Elsevier, 685 Route 202-206, Bridgewater, NJ 08807, USA. (Elsevier - www.elsevier.com; Clinical Therapeutics - www.elsevier.com/wps/product/cws_home/525050)
Our news journalists report that additional information may be obtained by contacting C.Y. Hu, GlaxoSmithKline R&D China, Clin Dev, Shanghai, People's Republic of China. Additional authors for this research include Y.M. Liu, Y. Liu, Q. Chen, W. Wang, K. Wu, J. Dong, J. Li, J.Y. Jia, C. Lu, S.X. Sun, C. Yu and X.N. Li (see also Immune System Diseases and Conditions).
Keywords for this news article include: Asia, Pharmaceuticals, Therapy, Shanghai, Fumarates, Treatment, Pharmacokinetics, Dicarboxylic Acids, Adverse Drug Reaction, People's Republic of China, Immune System Diseases and Conditions
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