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| Name | Class |
|---|---|
| KT&G Corporation | INDUSTRY |
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The purpose of this study is to investigate the safety and tolerability of MB12066 after a single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single oral dose.
Safety/ Tolerability evaluation
-Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC
Pharmacokinetic Evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB12066 10mg | Experimental |
| |
| MB12066 30mg | Active Comparator |
| |
| MB12066 100mg | Active Comparator |
| |
| MB12066 150mg | Active Comparator |
| |
| MB12066 200mg | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB12066 | Drug | MB12066 10mg, 100mg/tab. once oral dose MB12066 10, 30, 100, 150, 200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety/ Tolerability evaluation | Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC | from day-1 to day8-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Evaluation |
| between 0 (pre-dose) and 96 hours after a single oral dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, Professor | Clinical Research Institute of Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C014638 | beta-lapachone |
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|
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |