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This study is a randomized, open-label, single arm, multi-dose, crossover study to evaluate drug-drug interaction and safety after co-administration of D352 and D794 in healthy adult volunteers.
36 healthy subjects are administration of D352 and D794 following each part. Pharmacokinetic blood samples are collected 1d to 22d. The drug-drug interaction and safety are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D352-D352+D794(Part 1) | Experimental | Period 1: D352 1 tablet for 1 week, Period 2: D352 1 tablet and D794 4 capsule for 2 weeks |
|
| D794-D352+D794(Part 2) | Experimental | Period 1: D794 4 capsule for 2 weeks, Period 2: D352 1 tablet and D794 4 capsule for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D352 | Drug | 1 tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss of D352(Part 1) | Area under the D352 concentration in blood-time curve in steady-state | 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour |
| AUCtau,ss of D794(Part 2) | Area under the D794 concentration in blood-time curve in steady-state | 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour |
| Cmax,ss of D352(Part 1) | The maximum D352 concentration in steady-state | 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour |
| Cmax,ss of D794(Part 2) | The maximum D794 concentration in steady-state | 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with a history of hypersensitivity to any of the major ingredients or components of the investigational product
Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
Individuals who have a history of hypersensitivity or allergy to this ingredient because it contains Sunset Yellow FCF
Patients with the following diseases
Individuals with a history of gastrointestinal surgery or gastrointestinal disease that may affect drug absorption
Individuals who exceed the following condition with 1 month of the first administration of investigational product
Individuals who cannot restrict the intake of grapefruit or food containing grapefruit from three days before the first administration of investigational product until the final pharmacokinetic blood sample is collected
Individuals who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing administration
Individuals who have taken any specialty or herbal medicine within 2 weeks prior to the first administration, or any over-the-counter(OTC) or dietary supplement or vitamin preparation, including liver function supplements, within 1 week prior to the first administration
Individuals with a history of substance abuse or test positive for drugs of abuse on a urine screening test
Individuals who had been administered investigational product from other clinical study within the 6 months prior to the first administration
Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational product
Woman who are pregnant or breastfeeding
Individuals who have difficulty abstaining from omega-3-containing foods(such as oily fish, chia seeds, flaxseeds, walnuts, etc.) from 7 days before the first administration until the end of study
Individuals who determines that the tester is unfit to participate in the clinical trial in the final inclusion/exclusion criteria determined by combining the results of the clinical laboratory test conducted on the hospitalization date(-7D)
Those who are deemed insufficient to participate in this clinical study by investigators
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Gwanak-gu | Seoul | 08779 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C505695 | 1-stearoyl-d35-2-docosahexaenoyl-sn-glycero-3-phosphocholine |
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| D794 |
| Drug |
4 capsule |
|