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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1 (A) | Experimental | 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 |
|
| Part1 (B) | Experimental | 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 |
|
| Part2 (A) | Experimental | 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 |
|
| Part2 (B) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-330 | Drug |
| ||
| D086 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss of Candesartan and Amlodipine | Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30 | |
| AUCÏ„,ss of atorvastatin and 2-hydroxy atorvastatin | Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30 |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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|
| CKD-330 + D086 | Drug |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |