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The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | single administration : atorvastatin 40mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) |
|
| Part B | Experimental | single administration : metformin XR 1000mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period I : atorvastatin, Period II : atorvastatin and metformin | Drug |
| ||
| Period I : metformin, Period II : atorvastatin and metformin |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate PK interaction of atorvastatin and metformin | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate PK interaction of 2-OH-atorvastatin and metformin | Throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
Subjects with Symptoms of acute disease within 28days prior to study medication dosing
Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
Subjects with a history of abdominal surgery within food and water limit
Subjects with a history of clinically significant allergies including drug allergies
Subjects with anaphylaxis to atorvastatin and/or metformin
Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
Subjects with a history of myopathy
Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Clinical laboratory test values are outside the accepted normal range
Subjects with a history of drug, caffeine and alcohol abuse(caffeine > 5cups/day, cigarette > 10/day, alcohol > 30g/day) or have ever drank within 7 days 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
Donated blood within 60 days prior to dosing
Participated in a previous clinical trial within 60 days prior to dosing
Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration
Subjects considered as unsuitable based on medical judgement by investigators
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Pusan Paik Hospital | Busan | 614-735 | South Korea |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
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