Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- AUCτ,ss of Candesartan and Amlodipine
研究概览
简要总结
The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects
详细描述
An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study
Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330 affects pharmacokinetics of D086.
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males age of between 19 - 45 on the day of screening.
- •Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
- •Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
- •Not abnormal or not clinically significant lab values.
- •Subjects who signed informed consent form with good understandings after explanations by investigators.
排除标准
- •No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
- •Subjects showing angioedema as an adverse reaction to ACE inhibitors
- •Primary Hyperaldosteronism
- •History or family history of myopathy
- •Subjects with mental diseases or drug addiction
- •Allergic reactions to candesartan or amlodipine or atorvastatin
- •Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- •Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening
- •Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product
- •Subjects with abnormal lab values at least one below
- •(AST or ALT>2 fold of upper normal limit, Total bilirubin>2 fold of upper normal limit, CPK>2 fold of upper normal limit, K <3.5mEq/L or >5.5mEq/L, Estimated Glomerular filtration rate<60mL/min/1.73m2 by Modification)
- •Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy smoker(> 10 cigarettes per day) and unable to stop drinking during clinical trials
- •Subjects who previously participated in other clinical trials within 90 days
- •Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- •Subjects who were administered below medications within 30 days (cyclosporin, erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole, rifampicin, barbiturate : theses medicines could affect absorption, metabolism, distribution and excretion of candesartan,amlodipine and atorvastatin)
- •Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
- •Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).
- •Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.
- •Unable to use contraceptions.
研究组 & 干预措施
Part1 (A)
Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330
IPs for Period 2: CKD-330 + D086
干预措施: CKD-330 (Drug)
Part1 (A)
Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330
IPs for Period 2: CKD-330 + D086
干预措施: CKD-330 + D086 (Drug)
Part1 (B)
Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: CKD-330
干预措施: CKD-330 (Drug)
Part1 (B)
Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: CKD-330
干预措施: CKD-330 + D086 (Drug)
Part2 (A)
Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: D086
IPs for Period 2: CKD-330 + D086
干预措施: D086 (Drug)
Part2 (A)
Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: D086
IPs for Period 2: CKD-330 + D086
干预措施: CKD-330 + D086 (Drug)
Part2 (B)
Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: D086
干预措施: D086 (Drug)
Part2 (B)
Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: D086
干预措施: CKD-330 + D086 (Drug)
结局指标
主要结局
AUCτ,ss of Candesartan and Amlodipine
时间窗: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin
时间窗: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
次要结局
未报告次要终点