Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

Study Overview
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Brief Summary
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We investigate the potential pharmacokinetic drug-drug interaction between metformin extended release and rosuvastatin in healthy male volunteers who receive metformin extended release alone, rosuvastatin alone, and both together in a 3 period repeatedly.

Official Title
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Randomized, Open Label, Multiple-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium in Healthy Male Subjects

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, age 20 to 55 years. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2 Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing 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 one and a half times more than maximum normal range. Systolic blood pressure <90mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.

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: Crestor tablet 20 mg<br>Crestor tablet 20 mg single--->wash out---->Glucophage SR tablet 750 mg single---->washout--->Glucophage SR tablet 750 mg, Crestor tablet 20 mg both | Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg<br> <br> |
| Experimental: Glucophage SR tablet 750 mg and Crestor tablet 20 mg both<br>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both--->wash out---->Glucophage SR tablet 750 mg single------>washout--->Crestor tablet 20 mg single | Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg<br> <br> |
| Experimental: Glucophage SR tablet 750 mg<br>Glucophage SR tablet 750 mg single --->wash out---->Crestor tablet 20 mg single---->washout--->Glucophage SR tablet 750 mg, Crestor tablet 20 mg both | Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin, Rosuvastatin Cmaxss |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) | 
| metformin, rosuvastatin AUC |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin, Rosuvastatin tmaxss |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) | 
| Metformin, Rosuvastatin t1/2 |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) | 
| Metformin, Rosuvastatin C min,ss |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) | 
| Metformin, Rosuvastatin CL/Fss |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) | 
| Metformin, Rosuvastatin Vd/Fss |  | 0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16) |