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This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also investigate drug interaction between separate and combination administration.
Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day administration, 10 days washout after 5th day of administration.
All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | This arm is consist of 6 subject. Crestor 10mg and Glucodown 750mg for 5 day during period 1. Crestor 10mg alone for 5 day during period 2. Glucodown 750mg alone for 5 day during period 3. |
|
| 2 | Experimental | This arm is consist of 6 subject. Glucodown 750mg alone for 5 day during period 1. Crestor 10mg and Glucodown 750mg for 5 day during period 2. Crestor 10mg alone for 5 day during period 3. |
|
| 3 | Experimental | This arm is consist of 6 subject. Crestor 10mg alone for 5 day during period 1. Glucodown 750mg alone for 5 day during period 2. Crestor 10mg and Glucodown 750mg for 5 day during period 3. |
|
| 4 | Experimental | This arm is consist of 6 subject. Glucodown 750mg alone for 5 day during period 1. Crestor 10mg alone for 5 day during period 2. Crestor 10mg and Glucodown 750mg for 5 day during period 3. |
|
| 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg) | Drug | For co-administration,Crestor 1 tablet and Glucodown 1 tablet a day for 5 day.(1 period) For separate administration, Crestor 1 tablet a day for 5 day and Glucodown 1 tablet a day for 5 day. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau | 72 hr | |
| Css,max | 72 hr |
| Measure | Description | Time Frame |
|---|---|---|
| AUCss,last | 72 hr | |
| AUCss,inf | 72 hr | |
| Css,min |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyungsu Park, MD, Ph.D | Severance Hospital, Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24976448 | Derived | Lee D, Roh H, Son H, Jang SB, Lee S, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and metformin in healthy Korean male volunteers: a randomized, open-label, 3-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1171-81. doi: 10.1016/j.clinthera.2014.06.004. Epub 2014 Jun 26. |
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This arm is consist of 6 subject. Crestor 10mg alone for 5 day during period 1. Crestor 10mg and Glucodown 750mg for 5 day during period 2. Glucodown 750mg alone for 5 day during period 3. |
|
| 6 | Experimental | This arm is consist of 6 subject. Crestor 10mg and Glucodown 750mg for 5 day during period 1. Glucodown 750mg alone for 5 day during period 2. Crestor 10mg alone for 5 day during period 3. |
|
| 72 hr |
| Tss,max | 72 hr |
| t1/2 | 72 hr |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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