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This study was open-label, randomized, fed, single-dose, 2-groups, 2 periods, crossover designe to compare the safety and pharmacokinetics of UI068 and co-administration of UIC202205 and UIC202206.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UI068 | Experimental |
| |
| UIC202205, UIC202206 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administration of UI068 | Drug | Test |
| |
| administration of UIC202205, UIC202206 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Evaluation PK for Linagliptin and Metformin after single dose | 0 to 72hr |
| Cmax | Evaluation PK for Linagliptin and Metformin after single dose | 0 to 72hr |
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Inclusion Criteria:
Exclusion Criteria:
Clinically significant diseases related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and genitourinary system, mental/nervous system, musculoskeletal system, immune system, ENT system, skin system, and ophthalmic system. Those who have or have a history of
Those with a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
Those who took drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month of the first dose, or took drugs that may interfere with this clinical trial within 10 days of the first dose.
A person who participated in another clinical trial or bioequivalence test and administered an investigational drug within 6 months of the first administration date
Those who donated whole blood or component blood within 2 weeks or received a blood transfusion within 4 weeks of the first administration date
Those who meet the following conditions within 1 month of the first medication date
Alcohol consumption exceeding 21 drinks/week on average for men
For women, alcohol consumption exceeds an average of 14 drinks/week
(1 glass = 50 mL of soju or 30 mL of liquor or 250 mL of beer)
Smoking more than 20 cigarettes per day on average
Those who fall under the following
Patients with the following diseases
Persons judged by the principal investigator to be unsuitable for participation in this clinical trial for reasons other than the above selection/exclusion criteria
For female volunteers, those who are pregnant, suspected of being pregnant, or lactating
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H plus Yangji Hospital | Seoul | Gwanak-gu | 08779 | South Korea |
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| Drug |
Reference |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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