Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.