A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects

Study Overview
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Brief Summary
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to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Detailed Description
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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

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Drug: CKD-382, D860, D027


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 aged and 50 aged in healthy adult Body weight more than 50kg BMI more than 18.0 and under 27.0 Who has negative result on Helicobacter Pylori antibody test Exclusion Criteria: Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease Have a gastrointestinal disease history(including surgery) that can effect drug absorption Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Period 1: CKD-382 Period 2: D860 Period 3: D027 | Drug: CKD-382, D860, D027<br>* QD, PO for 7days<br>|
| Experimental: B<br>Period 1: CKD-382 Period 2: D027 Period 3: D860 | Drug: CKD-382, D860, D027<br>* QD, PO for 7days<br>|
| Experimental: C<br>Period 1: D860 Period 2: D027 Period 3: CKD-382 | Drug: CKD-382, D860, D027<br>* QD, PO for 7days<br>|
| Experimental: D<br>Period 1: D860 Period 2: CKD-382 Period 3: D027 | Drug: CKD-382, D860, D027<br>* QD, PO for 7days<br>|
| Experimental: E<br>Period 1: D027 Period 2: D860 Period 3: CKD-382 | Drug: CKD-382, D860, D027<br>* QD, PO for 7days<br>|
| Experimental: F<br>Period 1: D027 Period 2: CKD-382 Period 3: D860 | Drug: CKD-382, D860, D027<br>* QD, PO for 7days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-382, D860, D027