Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers

Study Overview
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Brief Summary
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To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition

Detailed Description
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An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers

Official Title
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An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: HCP1201, Fasted followed by fed
* Drug: HCP1201, Fed followed by fasted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age 20 55 years The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2 Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial Subject who has the ability and willingness to participate the whole period of trial Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times. Systolic Blood Pressure: lower than 90mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg History of relevant drug allergies or clinically significant hypersensitivity reaction. History of drug abuse or positive drug screening. Participation in other drug studies within 60days prior to the drug administration. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days. Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement) Subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin. Intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial. Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial. Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV). Genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication. Clinically inappropriate laboratory test result. Clinically inappropriate electrocardiogram result. Subjects who judged ineligible by the investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: HCP1201, Fasted followed by fed<br>HCP1201 dosing in the fasted state followed by fed dosing | Drug: HCP1201, Fasted followed by fed<br>* There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.<br>Drug: HCP1201, Fed followed by fasted<br>* There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.<br>|
| Experimental: HCP1201, Fed followed by fasted<br>HCP1201 dosing in the fed state followed by fasted dosing | Drug: HCP1201, Fasted followed by fed<br>* There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.<br>Drug: HCP1201, Fed followed by fasted<br>* There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin, rosuvastatin Cmax, AUClast |  | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin, rosuvastatin Tmax |  | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | 
| Metformin, rosuvastatin T1/2 |  | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | 
| Metformin, rosuvastatin AUCinf |  | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | 
| Metformin, rosuvastatin CL/F |  | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | 
| Metformin, rosuvastatin Vd/F |  | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h |