Healthy
Conditions
Brief summary
The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers
Interventions
DRUGPeriod I : atorvastatin, Period II : atorvastatin and metformin
DRUGPeriod I : metformin, Period II : atorvastatin and metformin
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing to adhere to protocol requirements and sign a informed consent form 2. Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9 3. Subjects with no history of any significant chronic disease 4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
Exclusion criteria
1. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing 2. Subjects with Symptoms of acute disease within 28days prior to study medication dosing 3. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines 4. Subjects with a history of abdominal surgery within food and water limit 5. Subjects with a history of clinically significant allergies including drug allergies 6. Subjects with anaphylaxis to atorvastatin and/or metformin 7. Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration 8. Subjects with a history of myopathy 9. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 10. Clinical laboratory test values are outside the accepted normal range * AST or ALT \>1.25 times to normal range * Total bilirubin \>1.5 times to normal range * Creatinine clearance \<90 mL/min 11. Subjects with a history of drug, caffeine and alcohol abuse(caffeine \> 5cups/day, cigarette \> 10/day, alcohol \> 30g/day) or have ever drank within 7 days prior to drug administration 12. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration 13. Donated blood within 60 days prior to dosing 14. Participated in a previous clinical trial within 60 days prior to dosing 15. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration 16. Subjects considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate PK interaction of atorvastatin and metformin | Throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate PK interaction of 2-OH-atorvastatin and metformin | Throughout the study |
Countries
South Korea
Outcome results
None listed