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A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects
A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026) |
|
| Group B | Experimental | Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I) |
|
| Group C | Experimental | Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-381(formulation I) | Drug | 1 tablet administered before the breakfast during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) | Evaluation PK esomeprazole after multiple dose | 0~24h |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | Evaluation PK esomeprazole after multiple dose | 0~24h |
| Tmax,ss(Time to maximum plasma concentration at steady state) | Evaluation PK esomeprazole after multiple dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Sang Yu, M.D | Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul University Hospital | Seoul | 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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| CKD-381(formulation II) | Drug | 1 tablet administered before the breakfast during 7 days |
|
| D026(Nexium 40mg) | Drug | 1 tablet administered before the breakfast during 7 days |
|
| 0~24h |
| t1/2(Terminal elimination half-life) | Evaluation PK esomeprazole after multiple dose | 0~24h |
| R(Accumulation ratio) | Evaluation PK esomeprazole after multiple dose | 0~24h |
| CLss/F(Apparent Clearance at steady state) | Evaluation PK esomeprazole after multiple dose | 0~24h |
| Vss/F(Apparent Volume of distribution at steady state) | Evaluation PK esomeprazole after multiple dose | 0~24h |
| Cmax(Maximum concentration of drug in plasma) | Evaluation PK esomeprazole after single dose | 0~24h |
| AUClast(Area under the plasma drug concentration-time curve from 0 to last) | Evaluation PK esomeprazole after single dose | 0~24h |
| Tmax(Time to maximum plasma concentration) | Evaluation PK esomeprazole after single dose | 0~24h |
| t1/2(Terminal elimination half-life) | Evaluation PK esomeprazole after single dose | 0~24h |
| CL/F(Apparent clearance) | Evaluation PK esomeprazole after single dose | 0~24h |
| Vd/F(Apparent volume of distribution) | Evaluation PK esomeprazole after single dose | 0~24h |
| D004066 | Digestive System Diseases |