期刊
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
卷 57, 期 11, 页码 5516-5520出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/AAC.00798-13
关键词
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资金
- Development Cooperation Ireland
- Bill and Melinda Gates Foundation
- U.S. Agency for International Development
- Dutch Ministry of Foreign Affairs
PA-824 is a novel nitroimidazo-oxazine being developed as an antituberculosis agent. Two randomized studies evaluated the pharmacokinetics and safety of a single oral dose of PA-824 administered to healthy adult subjects 30 min after a high-calorie, high-fat meal (fed state) versus after a minimum 10-h fast (fasted state). A total of 48 subjects were dosed in the two studies in a randomized crossover design with PA-824 at dose levels of 50, 200, or 1,000 mg in the fed state or fasted state. After the administration of PA-824, the geometric mean ratios of C-max and AUC(0-infinity) revealed an increase in exposure with the addition of a high-calorie, high-fat meal compared to the fasted state by 140 and 145% at 50 mg, 176 and 188% at 200 mg, and 450 and 473% at 50, 200, and 1,000 mg, respectively. The median T-max in the fed state was 4 h for the 50-mg dose and 5 h for the 200- and 1,000-mg doses. In the fasted state, the median T-max was 4 h for the 50- and 200- mg doses and 6.5 h for the 1,000-mg dose. All doses were well tolerated, and no serious adverse events occurred in either study. (This study has been registered at ClinicalTrials.gov under registration numbers NCT01828827 and NCT01830439.)
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