Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: combination drug: DW330SR, DW1030
* Drug: DW340


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at screening visit only 20 healthy men over the age of 40 years or less Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2 Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test Exclusion Criteria: Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery Those who have a clinically significant history of hypersensitivity to drug and food Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption Within 60 days those taking the other clinical trial drug Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs Within 30 days those who take food abnormally, that may affect ADME of drug Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion Within 14 days those who take OTC drug Those who showing positive for drug abuse concerns in urine drug testing Those who drink excessive alcohol or have history of alcoholism Heavy smoker and so on

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test 1<br>First phase: DW330SR+DW1030 7 days after Second phase: DW340 | Drug: combination drug: DW330SR, DW1030<br> <br> Drug: DW340<br> <br> |
| Experimental: Test 2<br>First phase: DW340 7 days after Second phase: DW330SR+DW1030 | Drug: combination drug: DW330SR, DW1030<br> <br> Drug: DW340<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of DW330SR |  | 9 days | 
| Cmax of DW340 |  | 9 days | 
| Cmax of DW1030 |  | 9 days | 
| AUClast of DW330SR |  | 9 days | 
| AUClast of DW340 |  | 9 days | 
| AUClast of DW1030 |  | 9 days |