An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Peak Plasma Concentration (Cmax)
研究概览
简要总结
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days
详细描述
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc Tablet 5mg) under fasting and FED conditions.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers of 18-40 years old, male or female.
- •Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and 45 kg for female.
- •No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.
- •Medically healthy subjects with clinically normal laboratory profiles and ECGs.
- •Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 3 months of last dose administration
- •Subjects are fully informed and voluntarily consent to participate in this study.
排除标准
- •History of allergy or hypersensitivity to amlodipine
- •Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
- •History of postural hypotension
- •Blood donation or lost more than 400mL blood within 3 months prior to the study
- •Use of medications within 2 weeks before the study
- •Volunteer in any other clinical drug study within 3 months prior to this study
- •Drug abuse or alcohol abuse (220ml beer /day or >5 times in 2 hours)
- •Smoker (>10 cigarettes/day)
- •A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
- •Abnormal chest X-ray results with clinical significance
- •Women of childbearing potential, pregnant and lactating women.
- •Other unfavorable factors diagnosed by investigators.
研究组 & 干预措施
LANDI-Amlodipine Besylate Tablet 5mg
During the study session, healthy subjects will be administered a single dose of LANDI-AmlodipineTablet 5mg under fasting and FED conditions.
干预措施: LANDI-Amlodipine Besylate Tablet 5mg (Drug)
Norvasc Tablets 5mg
During the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions.
干预措施: Norvasc Tablets 5mg (Drug)
结局指标
主要结局
Bioequivalence based on Peak Plasma Concentration (Cmax)
时间窗: 144 hours
次要结局
- Bioequivalence based on Area under the plasma concentration versus time curves (AUC)(144 hours)