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to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Period 1: CKD-382 Period 2: D860 Period 3: D027 |
|
| B | Experimental | Period 1: CKD-382 Period 2: D027 Period 3: D860 |
|
| C | Experimental | Period 1: D860 Period 2: D027 Period 3: CKD-382 |
|
| D | Experimental | Period 1: D860 Period 2: CKD-382 Period 3: D027 |
|
| E | Experimental | Period 1: D027 Period 2: D860 Period 3: CKD-382 |
|
| F | Experimental | Period 1: D027 Period 2: CKD-382 Period 3: D860 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-382, D860, D027 | Drug | QD, PO for 7days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Pharmacokinetic Endpoint | AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| Primary Pharmacodynamic Endpoint | Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose | 24 hours after multiple dose for 7 days compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| (1) Secondary Pharmacokinetic Endpoint | Cmax,ss Evaluation after multiple dose -Cmax,ss: Maximum concentration of drug in plasma | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacokinetic Endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minkyu Park, Ph.D | Contact | 043-269-8708 | mk_park@cbnuhctc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk Ntional University Hospital | Recruiting | Cheongju-si | South Korea |
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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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Tmax,ss Evaluation after multiple dose -Tmax,ss: Time to maximum plasma concentration |
| 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacokinetic Endpoint | t1/2ss Evaluation after multiple dose -t1/ss: Terminal elimination half life in steady state | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacokinetic Endpoint | CLss/F Evaluation after multiple dose -CLss/F: Apparent Clearance in steady-state | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacokinetic Endpoint | Vzss/F Evaluation after multiple dose -Vzss/F: Apparent Volume of Distribution at steady state | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacokinetic Endpoint | R Evaluation after multiple dose -R: Accumulation ratio | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacokinetic Endpoint | PTF Evaluation after multiple dose -PTF: Peak to Trough Fluctuation | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (2) Secondary Pharmacokinetic Endpoint | Cmax Evaluation after single dose -Cmax: Maximum concentration of drug in plasma | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (2) Secondary Pharmacokinetic Endpoint | AUC0-t Evaluation after single dose -AUC0-t: Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (2) Secondary Pharmacokinetic Endpoint | Tmax Evaluation after single dose -Tmax: Time to maximum plasma concentration | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (2) Secondary Pharmacokinetic Endpoint | t1/2 Evaluation after single dose -t1/2: Terminal elimination half-life | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (2) Secondary Pharmacokinetic Endpoint | CL/F Evaluation after single dose -CL/F: Apparent Clearance | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (2) Secondary Pharmacokinetic Endpoint | Vz/F Evaluation after single dose -Vz/F: Apparent Volume of Distribution | 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours |
| (1) Secondary Pharmacodynamic Endpoint | Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose | 24 hours after first dose compared to baseline |
| (2) Secondary Pharmacodynamic Endpoint | Percent of time with gastric pH≤4 for 24-hour interval after first or 7th dose | 24 hours after first dose and multiple dose for 7 days |
| D004066 | Digestive System Diseases |