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A dose block-randomized, open-label, parallel clinical trial
This study to evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 and Nexium tab and the effects of food influence the PK/PD of YYD601 in healthy adult male.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Set 1(YYD601 1 & Nexium) | Experimental | Set 1: YYD601 1 & Nexium |
|
| Set 2(YYD601 2 & Nexium) | Experimental | Set 2: YYD601 2 & Nexium |
|
| Set 3(YYD601 3 & Nexium) | Experimental | Set 3:YYD601 3 & Nexium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YYD601 1 | Drug | YYD601 1 |
| |
| YYD601 2 |
| Measure | Description | Time Frame |
|---|---|---|
| half-life | Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose) | Evaluate the before/after treatment period(5 days per phase) |
| Tmax | Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose) | Evaluate the before/after treatment period(5 days per phase) |
| Concentration | Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Cmax(after singlidose), Cmax.ss(after repeated dose) Cmin.ss(after single dose),Cmin.ss(after single dose) | Evaluate the before/after treatment period(5 days per phase) |
| AUC | Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) AUClast(after singlidose), AUCt(after repeated dose) AUCinf(after single dose), AUCinf(after repeated dose) | Evaluate the before/after treatment period(5 days per phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of pH>4 duration time | pH>4 duration time | Evaluate the before/after treatment period(5 days per phase) |
| % change in serum gastrin level | serum gastrin level |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event monitoring check up the adverse events | Adverse events | Evaluate the before/after treatment period(5 days per phase) |
| Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature) |
Inclusion criteria:
Exclusion criteria
healthy adult male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook national university hospital | Daegu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35281316 | Derived | Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and Pharmacodynamics of YYD601, a Dual Delayed-Release Formulation of Esomeprazole, Following Single and Multiple Doses in Healthy Adult Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2022 Mar 6;16:619-634. doi: 10.2147/DDDT.S338131. eCollection 2022. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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Each arm is assignted 10 persons[the percent of each arm is (treatmnet: comparator=4:1)]
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| Drug |
YYD601 2 |
|
| YYD601 3 | Drug | YYD601 3 |
|
| Nexium | Drug | Nexium |
|
| Evaluate the before/after treatment period(5 days per phase) |
vital sign(blood-pressure, pulse rate, temparature)
| Evaluate the before/after treatment period(5 days per phase) |
| Adverse event monitoring check up the 12-lead EKG | 12-lead EKG | Evaluate the before/after treatment period(5 days per phase) |
| Adverse event monitoring check up the clinical laboratory test | clinical laboratory test | Evaluate the before/after treatment period(5 days per phase) |
| Adverse event monitoring check up the physical | physical | Evaluate the before/after treatment period(5 days per phase) |
| Adverse event monitoring check up the administraton about the combined drugs | administraton about the combined drugs | Evaluate the before/after treatment period(5 days per phase) |
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |