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The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.
This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered.
For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC2129A + Reference drugs | Experimental | Period 1: GC2129A Period 2: Individual Components |
|
| Reference drugs + GC2129A | Experimental | Period 1: Individual Components Period 2: GC2129A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC2129A(Period 1) | Drug | Linagliptin and Metformin Hydrochloride Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameters - Cmax | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours |
| Pharmacokinetic (PK) parameters - AUCt | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameters - AUCinf | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours |
| Pharmacokinetic (PK) parameters - Tmax | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GC Biopharma Corp. | Contact | 82-(0)31-260-1934 | juyeon.kim@gccorp.com | |
| GC Biopharma Corp. | Contact | 82-(0)31-260-9318 | yumi@gccorp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus YangJi Hospital | Recruiting | Seoul | South Korea |
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an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design
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| Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1) |
| Drug |
Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets) |
|
| GC2129A(Period 2) | Drug | Linagliptin and Metformin Hydrochloride Tablet |
|
| Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2) | Drug | Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets) |
|
| 0-72hours |
| Pharmacokinetic (PK) parameters - t1/2 | Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum | 0-72hours |
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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