Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects: A Single-center, Open, Randomized, Single-dose, Crossover Study
试验速览
- 阶段
- 1 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects ≥18 years of age, with appropriate sex ratio
- •The body mass index is in the range of 19.0-27.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg
- •The subjects have no family planning within 3 months and could select contraceptive method.
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily
排除标准
- •Subjects with allergic constitution.
- •Being allergy to the study medications, smoking, alcohol abuse.
- •Participation in another clinical trial within 3 months.
- •Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
- •Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
研究组 & 干预措施
Dotilavir sodium tablet
干预措施: Dotilavir sodium tablet (Drug)
Dotilavir sodium tablet(Tivicay@)
干预措施: Dotilavir sodium tablet(Tivicay@) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 31 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
时间窗: 31days
Evaluation of Area under the plasma concentration versus time curve (AUC0-t）
Area under the plasma concentration versus time curve (AUC0-∞)
时间窗: 31days
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
次要结局
- Incidence of abnormal blood pressure(31 days)
- Incidence of Treatment-Emergent Adverse Events(31days)