Healthy
Conditions
Brief summary
The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.
Interventions
DRUGcombination administration
combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male volunteers in the age between 20 and 45 years old 2. The weight is over 55kg and is not exceed ±20% of ideal weight Ideal weight = \[height -100\]\*0.9 3. Subjects with no history of any significant chronic disease 4. Judged to be in good health on the basis of routine laboratory data obtained prior to study drug administration 5. Willing to adhere to protocol requirements and sign a informed consent form
Exclusion criteria
1. Subjects with Symptoms of acute disease within 28days prior to study medication dosing 2. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines 3. Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin 4. Subjects with a history of myopathy 5. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 6. Subject with the mean blood pressure of siDBP ≥ 150 mmHg or ≤ 90 mmHg and/or siSBP ≥ 95 mmHg or ≤ 50 mmHg at the screening visit 7. Subjects with abnormal HDL-cholesterol(\<35mg/dL) 8. Subjects with abnormal of serum potassium concentration (\<3.4 mEq/L of \>5.5 mEq/L in screening visit) 9. Subjects with a history of drug abuse 10. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing 11. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 14days prior to drug administration and OTC or vitamin within 7days prior to drug administration 12. Participated in a previous clinical trial within 60 days prior to dosing 13. Donated blood within 60 days prior to dosing 14. Subjects with a history of alcohol abuse(over 21 units/week, 1 unit = 10 g of pure alcohol) or is difficult to stop drinking within study 15. Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration 16. Subjects with a history of caffeine abuse or or is difficult to stop drinking within study 17. Subjects with biliary obstruction 18. Subjects with hepatic dysfunction (AST or ALT \>3 times to accepted normal range) 19. Subjects with moderate renal dysfunction (creatinine clearance (CLcr) \< 30mL/min) 20. Subjects considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate PK interaction of amlodipine and valsartan | from pre dosing to 24hr post dose | AUCss,τ, Css,max |
| To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin | from pre dosing to 24hr post dose | AUCss,τ, Css,max |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate PK interaction of amlodipine and valsartan | from pre dosing to 24hr post dose | tss,max, CLss/F, Css,min |
| To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin | from pre dosing to 24hr post dose | tss,max, CLss/F, Css,min |
Countries
South Korea
Outcome results
None listed