Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

NCT ID: NCT02185066

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-11-30

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 and metformin XR, in healthy volunteers.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Single-dose crossover

1. Reference: Atorvastatin 20mg and Metformin XR 500mg

2. Test: CJ-30056 20/500mg

Once daily Oral administration with 7days of washout period

Group Type: EXPERIMENTAL

Atorvastatin 20mg and Metformin XR 500mg (Reference)

Intervention Type: DRUG

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

CJ-30056 20/500mg (Test)

Intervention Type: DRUG

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Group 2

Single-dose crossover

1. Test: CJ-30056 20/500mg

2. Reference: Atorvastatin 20mg and Metformin XR 500mg

Once daily Oral administration with 7days of washout period

Group Type: EXPERIMENTAL

Atorvastatin 20mg and Metformin XR 500mg (Reference)

Intervention Type: DRUG

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

CJ-30056 20/500mg (Test)

Intervention Type: DRUG

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Interventions

Atorvastatin 20mg and Metformin XR 500mg (Reference)

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Intervention Type: DRUG

CJ-30056 20/500mg (Test)

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Intervention Type: DRUG

Eligibility Criteria

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 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong-lyul Ghim, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

Inje University Busan Paik Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

CJ_ATM_103

Identifier Type: -

Identifier Source: org_study_id