Healthy
Conditions
Keywords
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability
Brief summary
This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.
Interventions
DRUGadministration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
Sponsors
HK inno.N Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male volunteers in the age between 20 and 55 years old 2. The weight range 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 their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration 5. Willing to adhere to protocol requirements and sign a informed consent form
Exclusion criteria
1. History of clinically significant allergies including drug allergies 2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease 3. History of genetic muscular disease and family history 4. hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100) 5. AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( \> 1.5 times to normal range 6. Creatinine clearance \< 80mL/min 7. Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines 8. Serious injury, surgery and acute illness within 4 weeks prior to drug administration 9. History of alcohol, smoking abuse * alcohol \> 21 units/week, 1 unit=10g=12.5mL of pure alcohol * smoking \> 10 cigarettes/day 10. Use of any other medication, including herbal products, within the 2 weeks before dosing 11. Participated in a previous clinical trial within 3 months prior to drug administration 12. Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration 13. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration 14. Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL) 15. Subjects considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve) | 3 days | after steady state (Administration of Investigational Product 7day or 10days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2 | 3 days | steady state (Administration of Investigational Product) |
Countries
South Korea
Outcome results
None listed