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This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exforge 10/160mg(amlodipine 10mg, valsartan160mg) | Experimental | 1 tablet daily for 10days |
|
| crestor 20mg(rosuvastatin 20mg) | Experimental | 1 tablet daily for 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCÏ„(Area Under the Curve) | after steady state (Administration of Investigational Product 7day or 10days) | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2 | steady state (Administration of Investigational Product) | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant allergies including drug allergies
History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
History of genetic muscular disease and family history
hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
Creatinine clearance < 80mL/min
Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
Serious injury, surgery and acute illness within 4 weeks prior to drug administration
History of alcohol, smoking abuse
Use of any other medication, including herbal products, within the 2 weeks before dosing
Participated in a previous clinical trial within 3 months prior to drug administration
Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
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
Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
Subjects considered as unsuitable based on medical judgement by investigators
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| Name | Affiliation | Role |
|---|---|---|
| Young Ran Yoon PhD | Kyungpook university hostipal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook university hospital | Deagu | South Korea |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |