Healthy
Conditions
Keywords
volunteers
Brief summary
This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and metformin SR 750mg, in healthy volunteers.
Detailed description
To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg
Interventions
DRUGCJ-30056 20/750mg
fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg
DRUGAtorvastatin 20mg and Metformin SR 750mg
co-administration of Atorvastatin 20mg and Metformin SR 750mg
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing to adhere to protocol requirements and sign a informed consent form 2. Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight 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
Exclusion criteria
1. Use of barbital inducer or inhibitor medication within the 28 days before dosing 2. Symptom of an acute illness within 28 days prior to drug administration 3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME 4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines 5. History of clinically significant allergies including drug allergies 6. History of clinically significant allergies about atorvastatin or metformin 7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration 8. History of myopathy 9. Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.) 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 * e-GFR \<90 mL/min 11. History of drug, caffein(caffein \> 400mg/day), smoking (cigarette \> 10/day) or alcohol abuse(alcohol \> 30 g/day)or Subjects who have ever drink 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. Use of any other medication, including herbal products, within 10 days before dosing 16. Subjects considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) of Atorvastatin and Metformin | Up to 32 hours |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve(AUC) of Atorvastatin and Metformin | Up to 32 hours |
Outcome results
None listed