Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety Following Administration of CJ-30059 and Co-administration of Candesartan Cilexetil and Amlodipine Besylate in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine
研究概览
简要总结
This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in the age between 19 and 55 years old(inclusive)
- •Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
- •Available for the entire study period
- •Understand the requirements of the study and voluntarily consent to participate in the study
排除标准
- •Subjects with a history of gastrointestinal diseases which might significantly change absorption, distribution, metabolism and excretion (ADME) of medicines
- •Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 70 to 1000 mmHg for male subjects during screening
- •Subject with symptoms of acute disease within 14days prior to study drug administration
- •Subjects with a history of clinically significant allergies
- •Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, aspartate aminotransferase (AST) or alamin aminotransferase (ALT) >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit)
- •History of drug abuse
- •History of caffeine, alcohol, smoking abuse
- •caffeine(coffee, tea, coke) or grapefruit juice > 4 cups/day
- •smoking > 20 cigarettes/day
- •alcohol > 140 g/week
- •Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
- •Participation in any clinical investigation within 30 days prior to study drug administration
- •Subjects with whole blood donation within 60 days, component blood donation within 30days and blood transfusion within 30 days prior to study drug administration
- •Subjects who are judged unsuitable by investigators
研究组 & 干预措施
Sequence 1
Single-dose crossover
- Test: CJ-30059
- Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg
Once daily Oral administration with at least 14 days of washout period
干预措施: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) (Drug)
Sequence 1
Single-dose crossover
- Test: CJ-30059
- Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg
Once daily Oral administration with at least 14 days of washout period
干预措施: CJ-30059 (Test) (Drug)
Sequence 2
Single-dose crossover
- Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg
- Test: CJ-30059
Once daily Oral administration with at least 14 days of washout period
干预措施: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) (Drug)
Sequence 2
Single-dose crossover
- Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg
- Test: CJ-30059
Once daily Oral administration with at least 14 days of washout period
干预措施: CJ-30059 (Test) (Drug)
结局指标
主要结局
Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine
时间窗: Upto 72 hours
Area Under the plasma concentration-time Curve (AUC_last) of Candesartan
时间窗: Upto 72 hours
Maximum plasma concentration (Cmax) of Amlodipine
时间窗: Upto 72 hours
Maximum plasma concentration (Cmax) of Candesartan
时间窗: Upto 72 hours
次要结局
- Time to maximum plasma concentration of Amlodipine(Upto 72 hours)
- Time to maximum plasma concentration of Candesartan(Upto 72 hours)
- Elimination half-lie of Amlodipine(Upto 72 hours)
- Elimination half-lie of Candesartan(Upto 72 hours)