一项在健康参与者中评价 Afuresertib药物-药物相互作用（DDI）的单中心、非随机、开放、自身对照临床试验
[Translation] A single-center, non-randomized, open-label, self-controlled clinical trial evaluating the drug-drug interaction (DDI) of afuresertib in healthy participants
主要研究目的：
评价利福平对 Afuresertib 药代动力学的影响；
评价伊曲康唑对 Afuresertib 药代动力学的影响；
评价 Afuresertib 对咪达唑仑药代动力学的影响。 次要研究目的：
评价 Afuresertib 单独使用和与利福平合用时其代谢产物 M14、M28 的药代动力学特征；
评价 Afuresertib 单独使用和与伊曲康唑合用时其代谢产物 M14、M28 的药代动力学特征；
评价咪达唑仑单独使用和与 Afuresertib 合用时其代谢产物 1-羟基咪达唑仑的药代动力学特征；
评价 Afuresertib 单独使用和与利福平合用时在健康参与者中的安全性；
评价 Afuresertib 单独使用和与伊曲康唑合用时在健康参与者中的安全性；
评价 Afuresertib 与咪达唑仑合用时在健康参与者中的安全性；
评价 Afuresertib 在咪达唑仑 DDI 研究中多次给药后的 PK 特征。
[Translation] Primary study objectives:
To evaluate the effect of rifampicin on the pharmacokinetics of afuresertib;
To evaluate the effect of itraconazole on the pharmacokinetics of afuresertib;
To evaluate the effect of afuresertib on the pharmacokinetics of midazolam. Secondary study objectives:
To evaluate the pharmacokinetic profiles of afuresertib's metabolites, M14 and M28, when used alone and in combination with rifampicin;
To evaluate the pharmacokinetic profiles of afuresertib's metabolites, M14 and M28, when used alone and in combination with itraconazole;
To evaluate the pharmacokinetic profiles of its metabolite, 1-hydroxymidazolam, when used alone and in combination with afuresertib;
To evaluate the safety of afuresertib when used alone and in combination with rifampicin in healthy subjects;
To evaluate the safety of afuresertib when used alone and in combination with itraconazole in healthy subjects;
To evaluate the safety of afuresertib when used in combination with midazolam in healthy subjects;
To evaluate the PK profile of afuresertib after repeated dosing in a midazolam DDI study.
在中国健康参与者中单次口服 Afuresertib 片的单中心、随机、双盲设计的食物影响、对 QT/QTc 间期的影响及安全性试验
[Translation] A single-center, randomized, double-blind trial of the food effect, QT/QTc interval, and safety of afuresertib tablets in healthy Chinese participants
食物影响研究：
主要目的：
评价健康参与者在空腹和进食高脂餐状态下单次口服 Afuresertib 片的药代动力学特征以及食物对 Afuresertib 片药代动力学的影响。
次要目的：
评价 Afuresertib 片单次口服给药后其代谢产物 M14、M28 在健康参与者中的药代动力学特征；
评价健康参与者在空腹和进食高脂餐状态下单次口服 Afuresertib 片的安全性。 C-QTc 研究：
主要目的：
评价 Afuresertib 片单次口服给药后对健康参与者 QT/QTc 间期的影响。
次要目的：
评价 Afuresertib 片单次口服给药后对健康参与者其它 ECG 参数（HR、PR、QRS 间期、T 波形态和 U 波存在等）的影响；
评价 Afuresertib 片单次口服给药后 Afuresertib 及其代谢产物 M14、M28 在健康参与者中的药代动力学特征；
评价 Afuresertib 片单次口服给药后在健康参与者中的安全性。
[Translation] Food Effect Study:
Primary Objective:
To evaluate the pharmacokinetic characteristics of afuresertib tablets after a single oral dose in healthy participants in the fasting and high-fat meal states, and the effect of food on the pharmacokinetics of afuresertib tablets.
Secondary Objectives:
To evaluate the pharmacokinetic characteristics of afuresertib tablets and their metabolites, M14 and M28, in healthy participants after a single oral dose;
To evaluate the safety of afuresertib tablets after a single oral dose in healthy participants in the fasting and high-fat meal states. C-QTc Study:
Primary Objective:
To evaluate the effect of a single oral dose of afuresertib tablets on the QT/QTc interval in healthy participants. Secondary objectives:
To evaluate the effects of a single oral dose of afuresertib tablets on other ECG parameters (HR, PR, QRS interval, T wave morphology, and U wave presence) in healthy participants;
To evaluate the pharmacokinetic characteristics of afuresertib and its metabolites M14 and M28 in healthy participants after a single oral dose of afuresertib tablets;
To evaluate the safety of afuresertib tablets in healthy participants after a single oral dose.
/ Active, not recruitingNot Applicable 评估不同产地不同规格的Afuresertib 片剂在空腹状态下中国健康成年受试者中的单中心、开放、随机、单剂量、两周期、两序列、双交叉的生物等效性
[Translation] To evaluate the bioequivalence of Afuresertib tablets of different strengths from different origins in Chinese healthy adult subjects in the fasting state in a single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover
研究空腹状态下单次口服受试制剂Afuresertib片剂（境内生产）（规格：50 mg与75 mg）与参比制剂Afuresertib 片剂（境外生产）（规格：50 mg 与75 mg）在中国健体内的药代动力学，评价空腹状态口服不同产地制剂的生物等效性。
[Translation] The pharmacokinetics of a single oral dose of the test preparation Afuresertib tablets (produced domestically) (strengths: 50 mg and 75 mg) and the reference preparation Afuresertib tablets (produced overseas) (strengths: 50 mg and 75 mg) in Chinese healthy people were studied under fasting state, and the bioequivalence of oral preparations from different origins under fasting state was evaluated.
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