The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Food Effect Study of CJ-30056 20mg/500mg

Treatments: Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02160743

CJ_ATM_104

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

CJ-30056 20mg/500mg

Experimental group

Description:

fasting, fed

Treatment:

Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)

group 2

Experimental group

Description:

fed, fasting

Treatment:

Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)