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

HK inno.N Corporation0 sites42 target enrollmentFebruary 2015

ConditionsHealthy

InterventionsAtorvastatin 20mg and Metformin SR 750mg CJ-30056 20/750mg

DrugsAtorvastatin 20mg and Metformin SR 750mg CJ-30056 20/750mg

Overview

Phase: Phase 1
Intervention: Atorvastatin 20mg and Metformin SR 750mg
Conditions: Healthy
Sponsor: HK inno.N Corporation
Enrollment: 42
Primary Endpoint: Maximum plasma concentration (Cmax) of Atorvastatin and Metformin
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

HK inno.N Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing to adhere to protocol requirements and sign a informed consent form
•Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
•Subjects with no history of any significant chronic disease
•Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criteria

•Use of barbital inducer or inhibitor medication within the 28 days before dosing
•Symptom of an acute illness within 28 days prior to drug administration
•History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
•History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
•History of clinically significant allergies including drug allergies
•History of clinically significant allergies about atorvastatin or metformin
•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
•History of myopathy
•Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.)
•Clinical laboratory test values are outside the accepted normal range