Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)0-t
研究概览
简要总结
The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of 1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research Center, and fasted for 10 hours overnight until administration. The medicine was swallowed with 240 ml water at room temperature. Blood samples were taken before administration and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the plasma. The plasma samples were divided into two aliquots and stored at -80 °C until bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval between two administration, is 21 days. In the two periods, the operation was kept the same.
Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour before taking the medicine. Other procedures were the same as those in the fasting group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged 18 and above.
- •The body mass index is in the range of 18.6-28.5 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 following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
- •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
- •Being allergy to the study medications, smoking, alcohol abuse.
- •Participation in another clinical trial within 3 months.
研究组 & 干预措施
Amlodipine
amlodipine reference formulation at a single dose of 10 mg
干预措施: Amlodipine 10 mg (Drug)
Levamlodipine
levamlodipine test formulation at a single dose of 5 mg
干预措施: Levamlodipine 5 mg (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 64 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 64 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)
时间窗: 64 days
Evaluation of Peak Plasma Concentration (Cmax)
次要结局
- Incidence of abnormal pulse(64 days)
- Incidence of abnormal electrocardiogram waveform(64 days)
- Incidence of Treatment-Emergent Adverse Events(64 days)
- Incidence of abnormal blood pressure(64 days)
- Incidence of abnormal temperature(64 days)