Drug-drug Interaction Study Between UIC201601 and UIC201602

Study Overview
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Brief Summary
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An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.

Official Title
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An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201601 and UIC201602 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: UIC201602 and co-administration of UIC201601 and UIC201602
* Drug: UIC201601 and co-administration of UIC201601 and UIC201602


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight; Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires; Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests; Subjects able to read and understand a written informed consent, and willing to participate in the study. Exclusion Criteria: Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc); Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination; Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor; Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish; Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption; etc.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: UIC201602 and co-administration of UIC201601 and UIC201602<br>* UIC201602 4 Cap/day for 14 days Wash out 21 days UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days<br>|
| Experimental: Treatment B<br> | Drug: UIC201601 and co-administration of UIC201601 and UIC201602<br>* UIC201601 4 Tab/day for 7 days Wash out 14 days UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetics(AUCss,τ) of UIC201602 | Area under the serum drug concentration-time curve within a dosing interval at steady state | 0 hour to 24 hours after Day 14 and Day 49 administration | 
| Plasma pharmacokinetics(Css,max) of UIC201602 | Maximum concentration of drug in serum at steady state | 0 hour to 24 hours after Day 14 and Day 49 administration | 
| Plasma pharmacokinetics(AUCss,τ) of UIC201601 | Area under the serum drug concentration-time curve within a dosing interval at steady state | 0 hour to 24 hours after Day 7 and Day 35 | 
| Plasma pharmacokinetics(Css,max) of UIC201601 | Maximum concentration of drug in serum at steady state | 0 hour to 24 hours after Day 7 and Day 35 |