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This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and metformin SR 750mg, in healthy volunteers.
To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-30056 20/750mg | Experimental | fixed-dose combination of Atorvastatin 20mg and Metformin SR 750mg |
|
| Atorvastatin 20mg and Metformin SR 750mg | Experimental | co-administration of Atorvastatin 20mg and Metformin SR 750mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20mg and Metformin SR 750mg | Drug | co-administration of Atorvastatin 20mg and Metformin SR 750mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of Atorvastatin and Metformin | Up to 32 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve(AUC) of Atorvastatin and Metformin | Up to 32 hours |
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Inclusion Criteria:
Exclusion Criteria:
Use of barbital inducer or inhibitor medication within the 28 days before dosing
Symptom of an acute illness within 28 days 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
Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.)
Clinical laboratory test values are outside the accepted normal range
History of drug, caffein(caffein > 400mg/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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| Name | Affiliation | Role |
|---|---|---|
| Jong-lyul Ghim, MD.PhD | Inje University Busanpaik Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| CJ-30056 20/750mg | Drug | fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg |
|
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |