A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

Study Overview
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Brief Summary
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The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.

Official Title
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An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807
* Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9 Subjects with no history of any significant chronic disease Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data Available for the entire study period Willing to adhere to protocol requirements and sign a informed consent form. Exclusion Criteria: Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration Subjects who have symptom of an acute illness within 4 weeks prior to drug administration Subjects with a history of clinically significant allergies including drug allergies Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range) Subjects with a history of drug, caffeine or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day) Heavy smoker ( >10cigarettes/day) Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) Subjects who have donated plasma within 60days prior to drug administration Subjects who have participated in a clinical study within 90days prior to drug administration Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator (cimetidine within 7days prior to drug administration) Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br>SLM0807 | Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807<br> <br> |
| Experimental: Group2<br>SLM0807 and HKB0701 | Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Css,max and AUCinf |  | up to 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau, AUCt, Tmax |  | up to 24hrs |