一项开放、随机、在中国健康男性和女性受试者中进行的单次和多次服用ABT-335后非诺贝特酸的药代动力学研究
[Translation] An open-label, randomized, pharmacokinetic study of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects
主要目的:确定健康中国男性和女性受试者单次和多次服用ABT-335后非诺贝特酸的药代动力学特征。 安全性目的:评价健康中国男性和女性受试者单次和多次服用ABT-335 45 mg和135 mg胶囊制剂后的安全性和耐受性。
[Translation] Primary objective: To determine the pharmacokinetic profile of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects. Safety objective: To evaluate the safety and tolerability of ABT-335 45 mg and 135 mg capsule formulations after single and multiple doses in healthy Chinese male and female subjects.
一项在健康中国受试者中评价ABT-493/ABT-530片剂药代动力学、安全性和耐受性的1期、开放、多剂量研究
[Translation] A Phase 1, open-label, multiple-dose study to evaluate the pharmacokinetics, safety, and tolerability of ABT-493/ABT-530 tablets in healthy Chinese subjects
评价健康中国成年受试者在非空腹条件下重复口服ABT-493/ABT-530时的药代动力学、安全性和耐受性
[Translation] To evaluate the pharmacokinetics, safety and tolerability of ABT-493/ABT-530 after repeated oral administration under non-fasting conditions in healthy Chinese adult subjects
一项12周随机双盲研究比较非诺贝特酸与安慰剂在中国混合性血脂异常或高甘油三酯血症受试者中的疗效和安全性
[Translation] A 12-week randomized, double-blind study comparing the efficacy and safety of fenofibric acid with placebo in Chinese subjects with mixed dyslipidemia or hypertriglyceridemia
本项研究主要目的是在所有混合性血脂异常和高甘油三酯血症患者中评价非诺贝特酸治疗后降低甘油三酯(TG)和升高高密度脂蛋白胆固醇(HDL-C)的疗效;在混合性血脂异常患者中评价非诺贝特酸联合他汀类药物和他汀类单药治疗后降低TG和升高HDL-C的疗效。在高甘油三酯血症患者中评价非诺贝特酸治疗后降低TG和升高HDL-C的疗效。
[Translation] The main purpose of this study is to evaluate the efficacy of fenofibric acid in reducing triglycerides (TG) and increasing high-density lipoprotein cholesterol (HDL-C) after treatment in all patients with mixed dyslipidemia and hypertriglyceridemia; to evaluate the efficacy of fenofibric acid combined with statins and statins alone in reducing TG and increasing HDL-C in patients with mixed dyslipidemia. To evaluate the efficacy of fenofibric acid in reducing TG and increasing HDL-C in patients with hypertriglyceridemia.
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