Food Effect Study of CJ-30056 20mg/500mg
Conditions
Brief summary
This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) in healthy male subjects
Interventions
DIETARY_SUPPLEMENTCJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)
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 45 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 20 and 45 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 4 weeks before dosing 2. Symptom of an acute illness within 4 weeks 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. 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 10. History of drug, caffein(caffein \> 5 cups/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 11. 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 12. Donated blood within 60 days prior to dosing 13. Participated in a previous clinical trial within 60 days prior to dosing 14. Use of any other medication, including herbal products, within 10 days before dosing 15. Subjects considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak plasma concentration (Cmax) of atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose |
| Peak plasma concentration (Cmax) of metformin | 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose |
| area under the plasma concentration versus time curve (AUC0-t) of atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose |
| area under the plasma concentration versus time curve (AUC0-t) of metformin | 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Tmax of Atorvastatin, 2-OH-atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| Peak plasma concentration (Cmax) of 2-OH-atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose |
| CL/F of atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| t1/2β of Atorvastatin, 2-OH-atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| Vz/F of atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
| area under the plasma concentration versus time curve (AUC0-t) of 2-OH-atorvastatin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose |
| AUCinf of Atorvastatin, 2-OH-atorvastatin and metformin | 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose |
Countries
South Korea
Outcome results
None listed