Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg

Study Overview
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Brief Summary
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To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state, respectively.

Detailed Description
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An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: HCP1201 500/10mg
* Drug: Metformin SR 500mg
* Drug: Rosuvastatin 10mg


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. Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study History of relevant drug allergies or clinically significant hypersensitivity reaction.

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, Part 1<br>Participants received a single oral dose of the HCP1201 500/10 mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2). | Drug: HCP1201 500/10mg<br>* 500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.<br>|
| Active Comparator: Metformin and Rosuvastatin, Part1<br>Participants received a single oral dose of coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2). | Drug: Metformin SR 500mg<br>* Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.<br>* Other names: Glucophage SR 500 mg;Drug: Rosuvastatin 10mg<br>* Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.<br>* Other names: Crestor 10mg;|
| Experimental: HCP1201, Part 2<br>Participants received a single oral dose of the HCP1201 500/10mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2). | Drug: HCP1201 500/10mg<br>* 500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.<br>|
| Active Comparator: Metformin and Rosuvastatin, Part 2<br>Participants received a single oral dose of coadministration of Metformin SR 500mg and Rosuvastatin 10mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2). | Drug: Metformin SR 500mg<br>* Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.<br>* Other names: Glucophage SR 500 mg;|

What is the study measuring?
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Primary Outcome Measures

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