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The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose intake of both combinations in order to answer the following questions:
16 subjects were randomized to each of 2 sequence groups which have different treatment order of the study drug in each period.
Only healthy volunteers had screening tests such as medical inquiry, physical examination, clinical laboratory test, etc. within 4 weeks (-28d ~ -1d) prior to drug administration (1d) and those determined eligible for this study were selected and randomized between screening and 1 day prior to the first administration of study medication (-1d). Then, the subjects were admitted to the clinical research center of Seoul National University Hospital by 9 p.m. of -1d and then, they were not allowed to take anything except water.
After one week of washout period, subjects went on to the second phase of treatment period and were administered according to the treatment order in a crossover way. For the subjects who completed the study, post-study visit tests were performed after a designated time had passed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR sequential group | Experimental | Amaryl-M 1/500 mg in period 1, Amaryl-M 2/500 mg in period 2 |
|
| RT sequential group | Active Comparator | Amaryl-M 2/500 mg in period 1, Amaryl-M 1/500 mg in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amaryl-M 2/500 mg | Drug | single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug concentrations of glimepiride and metformin, PK parameters: AUCt, AUCinf, Cmax, Tmax, T1/2 | pre-dose (= 1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 30 hrs after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination, clinical laboratory tests | Screening, 2 day, 9 day, 13-15 day | |
| Vital sign | screening, 1 day, 2 day, 8 day, 9 day, 13-15 day | |
| Adverse event |
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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 |
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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 1/500 mg | Drug | single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively |
|
|
| 1 day, 2 day, 8 day, 9 day, 13-15 day |