Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration.

Detailed Description
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Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP_C003 Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP_C003 after Single Oral Administration to Healthy Male Subjects.

Official Title
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Randomized, Open, Cross-over, Single Dose Study to Evaluate the PK, Safety/Tolerability of BCWP_C003 Compared to Coadministration of Rosuvastatin and Metformin SR, and the Food Effect on the PK of BCWP_C003 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Metformin
* Drug: BCWP_C003


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Male Volunteer, age 19 to 45 years at the time of screening Body weight is not less than 55kg, not more than 90kg and the result of Body Mass Index(BMI) is not less than 18.5, not more than 25.0 Subject who has no congenital, chronic disease, and no disease symptom or finding in medical examination result Subject who comprehended the purpose, contents of the study, property of clinical drug and signed the informed consent to participate in the trial having the willingness Exclusion Criteria: Subject who has history of hypersensitivity reaction for relevant drug(statin, biguanide) or clinically significant hypersensitivity reaction Subject who has history or presence of clinically disease in liver, kidney, gastrointestinal tract, respiratory system, musculoskeletal, endocrine system, mental disorder, blood-tumor, cardiovascular. Particulary, subject who has bleeding disorder or tend to be bleeding with bruised easily Subject who has family history of hereditary muscular disorder or muscular side effect Subject who has history of gastrointestinal tract disorder which can affect the drug absorption or surgery(excluding appendectomy, hernia surgery) Subject who had taken diagnosis with peptic ulcer within 2 month prior to the drug administration Subject who has results of clinical laboratory test as follows : AST, ALT level exceed the normal range more than 1.5 times Total bilirubin level exceed the normal range more than 1.5 times Creatinine clearance under 60mL/min calculated by MDRD In the vital sign, systolic blood pressure is more than 150mmHg, less than 90mmHg or diastolic blood pressure is more than 95mmHg, less than 50mmHg Subject who has presence or history of drug abuse, or positive screening for drug abuse → Alcohol abuse defines to drink over 21 unit/week(alcohol 1unit = 10g = 12.5 mL) persistingly Subject who participated in another clinical trial within 3 month prior to the drug administration Subject who had taken medicine(Barbital etc) related drug metabolizing enzyme induction or inhibition within 1 month prior to the drug administration Subject who had taken prescription drug or oriental medicine within 2 weeks or OTC drug or vitamin formulation within a week prior to the drug administration Subject who had a diet which can affect the absorption, distribution, metabolism or elimination of Rosuvastatin/Metformin (Particulary, Grapefruit - within 48h prior to the drug administration) Subject who donated whole blood within 2 month or component blood within 1 month prior to the drug administration Subject who smokes more than 10 cigarettes per day Subject who has positive HBsAg, HCV Ab or HIV Ab Subject who is judged to be ineligible by principal investigator or sub-investigator according to various test results

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 6 x 3
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1(ABC)<br>Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day. | Drug: Rosuvastatin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Crestor 10mg(Rosuvastatin);Drug: Metformin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Glucophage XR 1000mg(Metformin);Drug: BCWP_C003<br>* Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.<br>* Other names: Rosuvastatin and Metformin;|
| Experimental: Treatment Sequence 2(ACB)<br>Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day. | Drug: Rosuvastatin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Crestor 10mg(Rosuvastatin);Drug: Metformin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Glucophage XR 1000mg(Metformin);Drug: BCWP_C003<br>* Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.<br>* Other names: Rosuvastatin and Metformin;|
| Experimental: Treatment Sequence 3(BAC)<br>Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day. | Drug: Rosuvastatin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Crestor 10mg(Rosuvastatin);Drug: Metformin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Glucophage XR 1000mg(Metformin);Drug: BCWP_C003<br>* Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.<br>* Other names: Rosuvastatin and Metformin;|
| Experimental: Treatment Sequence 4(BCA)<br>Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day. | Drug: Rosuvastatin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Crestor 10mg(Rosuvastatin);Drug: Metformin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Glucophage XR 1000mg(Metformin);Drug: BCWP_C003<br>* Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.<br>* Other names: Rosuvastatin and Metformin;|
| Experimental: Treatment Sequence 5(CAB)<br>Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day. | Drug: Rosuvastatin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Crestor 10mg(Rosuvastatin);Drug: Metformin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Glucophage XR 1000mg(Metformin);Drug: BCWP_C003<br>* Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.<br>* Other names: Rosuvastatin and Metformin;|
| Experimental: Treatment Sequence 6(CBA)<br>Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day. | Drug: Rosuvastatin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Crestor 10mg(Rosuvastatin);Drug: Metformin<br>* Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.<br>* Other names: Glucophage XR 1000mg(Metformin);Drug: BCWP_C003<br>* Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.<br>* Other names: Rosuvastatin and Metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosuvastatin AUClast | Rosuvastatin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Rosuvastatin Cmax | Rosuvastatin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Metformin AUClast | Metformin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Metformin Cmax | Metformin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-desmethyl rosuvastatin Cmax | N-desmethyl rosuvastatin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| N-desmethyl rosuvastatin AUClast | N-desmethyl rosuvastatin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| N-desmethyl rosuvastatin AUCinf | N-desmethyl rosuvastatin AUCinf | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf | Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax | Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2 | Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2 | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F | Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | 
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F | Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h |