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This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-383 in healthy volunteers
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is 7 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-Fed | Experimental | Period 1: A single oral dose of 1 tablet under fasting condition, Period 2: A single oral dose of 1 tablet under fed condition |
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| Fed-Fast | Experimental | Period 1: A single oral dose of 1 tablet under fed condition, Period 2: A single oral dose of 1 tablet under fasting condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-383 | Drug | QD, PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of CKD-383 | Area under the CKD-383 concentration in blood-time curve from 0 to t | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours |
| Cmax of CKD-383 | The maximum CKD-383 concentration in blood sampling time t | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours |
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Inclusion Criteria:
Healthy adults volunteers between the ages of 19 years to 55 years.
Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) < 30.0 kg/m2 and total body weight ≥ 50 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
Following vital signs results at screening
Individuals who is determined by investigators to be suitable as a test subject as a result of the examination conducted at the time of screening
Individuals who agreed proper contraception during the study and did consent to not donation of sperm 7 days after the last dose of study drug
Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bumin Hospital | Gangseo-gu | Seoul | 07590 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |