CKD-330 Drug-Drug Interaction Study (Amlodipine)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.

Official Title
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A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine Monotherapy in Healthy Male Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amlodipine 10mg
* Drug: Amlodipine 10mg/Candesartan 32mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening). Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m² When volunteer in screening, Must include under the items. 100 mmHg ≤ sitting SBP <140 mmHg 60 mmHg ≤ sitting DBP < 90 mmHg 45 bpm ≤ Pulse < 95 bpm Those who decided to join the clinical trials by themselves and to comply with the precautions written consent. Exclusion Criteria: A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease. Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery). The history of clinically significant hypersensitivity reaction about Investigational drugs and foods. The history of drug abuse or drug abuse showed a positive for urine drug test. Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing. Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing. Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing. A heavy alcohol consumer(alcohol>3cup/day or 3times/week within last 1month) A heavy smoker(cigarette>10cigarettes/day) The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis). Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL. Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable). The result of 12-lead ECG in screening test is QTc>450msec. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A(Amlodipine 10mg)<br>Amlodipine 10mg 1T, PO, QD for 9days | Drug: Amlodipine 10mg/Candesartan 32mg<br>* Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days<br>* Other names: Norvasc Tab. 10mg/Atacand Tab. 32mg;|
| Experimental: B(Amlodipine 10mg/Candesartan 32mg)<br>Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days | Drug: Amlodipine 10mg<br>* Amlodipine 10mg 1T, PO, QD for 9days<br>* Other names: Norvasc Tab. 10mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss of Amlodipine |  | 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h | 
| Cmax,ss of Amlodipine |  | 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax,ss of Amlodipine |  | 1D 0h, 8D 0h, 9D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 10D 0h, 11D 0h |