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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 and metformin XR, in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Single-dose crossover
Once daily Oral administration with 7days of washout period |
|
| Group 2 | Experimental | Single-dose crossover
Once daily Oral administration with 7days of washout period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20mg and Metformin XR 500mg (Reference) | Drug | Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of Atorvastatin | Upto 36 hours | |
| Maximum plasma concentration (Cmax) of Metformin | Upto 24 hours | |
| Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin | Upto 36 hours | |
| Area Under the plasma concentration-time Curve (AUC0-t) of Metformin | Upto 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of 2-OH-atorvastatin | Upto 36 hours | |
| Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin | Upto 36 hours | |
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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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| Name | Affiliation | Role |
|---|---|---|
| Jong-lyul Ghim, MD. PhD | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 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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|
| CJ-30056 20/500mg (Test) | Drug | Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between. |
|
| CL/F of Atorvastatin and Metformin |
| Upto 36 hours |
| Vd/F of Atorvastatin and Metformin | Upto 36 hours |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |