Clinical trial NCT02160743: The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food Effect Study of CJ-30056 20mg/500mg
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 28
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Peak plasma concentration (Cmax) of atorvastatin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
measure: Peak plasma concentration (Cmax) of metformin
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
measure: area under the plasma concentration versus time curve (AUC0-t) of atorvastatin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
measure: area under the plasma concentration versus time curve (AUC0-t) of metformin
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 hours post dose
Secondary outcomes:
measure: Peak plasma concentration (Cmax) of 2-OH-atorvastatin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
measure: Vz/F of atorvastatin and metformin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
measure: area under the plasma concentration versus time curve (AUC0-t) of 2-OH-atorvastatin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 hours post dose
measure: AUCinf of Atorvastatin, 2-OH-atorvastatin and metformin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
measure: Tmax of Atorvastatin, 2-OH-atorvastatin and metformin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
measure: t1/2β of Atorvastatin, 2-OH-atorvastatin and metformin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
measure: CL/F of atorvastatin and metformin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36 hours post dose
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
References: