Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor 20mg/Glucophage SR 750mg

NCT ID: NCT02378441

Last Updated: 2016-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

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 20mg and metformin SR 750mg, in healthy volunteers.

Detailed Description

To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg

Conditions

Healthy

Keywords

volunteers

Study Design

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

Study Groups

CJ-30056 20/750mg

fixed-dose combination of Atorvastatin 20mg and Metformin SR 750mg

Group Type: EXPERIMENTAL

Atorvastatin 20mg and Metformin SR 750mg

Intervention Type: DRUG

co-administration of Atorvastatin 20mg and Metformin SR 750mg

CJ-30056 20/750mg

Intervention Type: DRUG

fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg

Atorvastatin 20mg and Metformin SR 750mg

co-administration of Atorvastatin 20mg and Metformin SR 750mg

Group Type: EXPERIMENTAL

Atorvastatin 20mg and Metformin SR 750mg

Intervention Type: DRUG

co-administration of Atorvastatin 20mg and Metformin SR 750mg

CJ-30056 20/750mg

Intervention Type: DRUG

fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg

Interventions

Atorvastatin 20mg and Metformin SR 750mg

co-administration of Atorvastatin 20mg and Metformin SR 750mg

Intervention Type: DRUG

CJ-30056 20/750mg

fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg

Intervention Type: DRUG

Other Intervention Names

Atorvastatin (Lipitor) and Metformin (Glucophage SR); not yet approved

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 28 days before dosing

2. Symptom of an acute illness within 28 days 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. Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.)

10. 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

11. History of drug, caffein(caffein > 400mg/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

12. 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

13. Donated blood within 60 days prior to dosing

14. Participated in a previous clinical trial within 60 days prior to dosing

15. Use of any other medication, including herbal products, within 10 days before dosing

16. 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 Busanpaik Hospital

Other Identifiers

CJ_ATM_105

Identifier Type: -

Identifier Source: org_study_id