PK/PD Clinical Trial of YYD601 in Healthy Adult Male

Study Overview
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Brief Summary
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A dose block-randomized, open-label, parallel clinical trial

Detailed Description
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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.

Official Title
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A Dose Blocked-randomized, Open-label, Parallel Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 After Oral Administration in Healthy Adult Male Volunteers(Phase 1)

Conditions
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GERD

Intervention / Treatment
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* Drug: YYD601 1
* Drug: YYD601 2
* Drug: YYD601 3
* Drug: Nexium


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy adult male above 19 years old when getting a screening test. Subjects who have over 50kg weight, included in the IBW± 20% range. [IBW(kg)={height(cm)-100}x0.9 Subjects who haven't any congenital or chronic disease, and any other disease following the medical examination. Subjects who are confirmed as a participant by the serum test, hematologital test, blood chemistry tests, urine tests, and clinical laboratory test, 12-lead EKG etc following the characteristics aboht the IP within the 3 weeks before investogator products are administrated. Subjects who voluntarily decide to participated in this trial after comletely understand about this clinical trial. Exclusion criteria Subjects who are judged not suitable to participated in this trial. Other specific exlusion criteria is identified in the protocol.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

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: Parallel Assignment
Interventional Model Description: Each arm is assignted 10 persons[the percent of each arm is (treatmnet: comparator=4:1)]
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Set 1(YYD601 1 & Nexium)<br>Set 1: YYD601 1 & Nexium | Drug: YYD601 1<br>* YYD601 1<br>Drug: Nexium<br>* Nexium<br>|
| Experimental: Set 2(YYD601 2 & Nexium)<br>Set 2: YYD601 2 & Nexium | Drug: YYD601 2<br>* YYD601 2<br>Drug: Nexium<br>* Nexium<br>|
| Experimental: Set 3(YYD601 3 & Nexium)<br>Set 3:YYD601 3 & Nexium | Drug: YYD601 3<br>* YYD601 3<br>Drug: Nexium<br>* Nexium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Evaluate the before/after treatment period(5 days per phase) |