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This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of "CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)" in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-30056 20mg/500mg | Experimental | fasting, fed |
|
| group 2 | Experimental | fed, fasting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | |
| Peak plasma concentration (Cmax) of metformin | 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose | |
| area under the plasma concentration versus time curve (AUC0-t) of atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | |
| area under the plasma concentration versus time curve (AUC0-t) of metformin | 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of 2-OH-atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose | |
| Vz/F of atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
Symptom of an acute illness within 4 weeks prior to drug administration
History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
History of clinically significant allergies including drug allergies
History of clinically significant allergies about atorvastatin or metformin
Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
History of myopathy
Clinical laboratory test values are outside the accepted normal range
History of drug, caffein(caffein > 5 cups/day), smoking (cigarette > 10/day) or alcohol abuse(alcohol > 30 g/day)or Subjects who have ever drink 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
Use of any other medication, including herbal products, within 10 days before dosing
Subjects considered as unsuitable based on medical judgement by investigators
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| area under the plasma concentration versus time curve (AUC0-t) of 2-OH-atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose |
| AUCinf of Atorvastatin, 2-OH-atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| Tmax of Atorvastatin, 2-OH-atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| t1/2β of Atorvastatin, 2-OH-atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| CL/F of atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |