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

Phase 1

Completed

• Conditions: Food Effect Study of CJ-30056 20mg/500mg
• Interventions: Dietary Supplement: CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)

• Registration Number: NCT02160743
• Lead Sponsor: HK inno.N Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-28
• Primary Completion: 2014-06
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-11
• Study Completion: 2014-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CJ-30056 20mg/500mg	CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)	fasting, fed
group 2	CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)	fed, fasting

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
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

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of