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

A Randomized, Open-labeled, Single-dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety of CJ-30056 20/750mg and Co-administration of Lipitor® 20mg and Glucophage SR 750mg in Fed Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Atorvastatin 20mg and Metformin SR 750mg; Drug: CJ-30056 20/750mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CJ-30056 20/750mg; fixed-dose combination of Atorvastatin 20mg and Metformin SR 750mg	Drug: Atorvastatin 20mg and Metformin SR 750mg; co-administration of Atorvastatin 20mg and Metformin SR 750mg; Other Names: Atorvastatin (Lipitor) and Metformin (Glucophage SR); Drug: CJ-30056 20/750mg; fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg; Other Names: not yet approved
EXPERIMENTAL: Atorvastatin 20mg and Metformin SR 750mg; co-administration of Atorvastatin 20mg and Metformin SR 750mg	Drug: Atorvastatin 20mg and Metformin SR 750mg; co-administration of Atorvastatin 20mg and Metformin SR 750mg; Other Names: Atorvastatin (Lipitor) and Metformin (Glucophage SR); Drug: CJ-30056 20/750mg; fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg; Other Names: not yet approved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of Atorvastatin and Metformin	Up to 32 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the curve(AUC) of Atorvastatin and Metformin	Up to 32 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Jong-lyul Ghim, MD.PhD, Inje University Busanpaik Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (ESTIMATE): March 4, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: volunteers
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Metformin
• Other Study ID Numbers: CJ_ATM_105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO