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The pharmacokinetics of glimepiride and metformin will be compared after single dose intake of both combinations in order to answer to the following questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR sequential group | Experimental | Amaryl M SR 1/500 mg in period 1 and Amaryl M SR 2/500 mg in period 2 |
|
| RT sequential group | Active Comparator | Amaryl M SR 2/500 mg in period 1 and Amaryl M SR 1/500 mg in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amaryl M SR 1/500 mg | Drug | single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast/D, Cmax/D | pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, T1/2 | pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration | |
| Vital signs, ECG, physical examination, clinical laboratory tests | screening, treatment period 1 & 2, Post-study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, Professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22036245 | Derived | Shin KH, Kim SE, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. Pharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther. 2011 Nov;33(11):1809-18. doi: 10.1016/j.clinthera.2011.10.003. Epub 2011 Oct 27. |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Amaryl M SR 2/500 mg | Drug | single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group |
|
|
| Adverse Event | Treatment period 1 & 2, Post-study visit |