Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers

Study Overview
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Brief Summary
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The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.

Official Title
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A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rosuvastatin, Metformin, YH14755
* Drug: YH14755


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. Administration of other investigational products within 3 months prior to the first dosing. Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study). Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Ages Eligible for Study
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Minimum Age: 19 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 of Study A<br>single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755 | Drug: Rosuvastatin, Metformin, YH14755<br>* single dose<br>* Other names: Crestor, GlucodaunOR, YH14755;|
| Experimental: Group 2 of Study A<br>single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin | Drug: Rosuvastatin, Metformin, YH14755<br>* single dose<br>* Other names: Crestor, GlucodaunOR, YH14755;|
| Experimental: Group 1 of Study B<br>single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast | Drug: YH14755<br>* single dose<br>|
| Experimental: Group 2 of Study B<br>single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state | Drug: YH14755<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of rosuvastatin and metformin |  | 0 48hr, totally 17 points | 
| Cmax of rosuvastatin and metformin |  | 0 48hr, totally 17 points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of rosuvastatin and metformin |  | 0 48hr, totally 17 points | 
| t1/2 of rosuvastatin and metformin |  | 0 48hr, totally 17 points | 
| %AUC of rosuvastatin and metformin |  | 0 48hr, totally 17 points | 
| AUCinf of rosuvastatin and metformin |  | 0 48hr, totally 17 points |