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

NCT02378441 | Completed Phase 1

• 1 other identifier: CJ_ATM_105
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• Maximum plasma concentration (Cmax) of Atorvastatin and Metformin

  Up to 32 hours

Secondary Outcomes (1)

• Area under the curve(AUC) of Atorvastatin and Metformin

  Up to 32 hours

Study Arms (2)

CJ-30056 20/750mg

EXPERIMENTAL

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

Drug: Atorvastatin 20mg and Metformin SR 750mg; Drug: CJ-30056 20/750mg

Atorvastatin 20mg and Metformin SR 750mg

EXPERIMENTAL

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

Drug: Atorvastatin 20mg and Metformin SR 750mg; Drug: CJ-30056 20/750mg

Interventions

Atorvastatin 20mg and Metformin SR 750mg DRUG

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

Also known as: Atorvastatin (Lipitor) and Metformin (Glucophage SR)

Atorvastatin 20mg and Metformin SR 750mg; CJ-30056 20/750mg

CJ-30056 20/750mg DRUG

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

Also known as: not yet approved

Atorvastatin 20mg and Metformin SR 750mg; CJ-30056 20/750mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• AST or ALT \>1.25 times to normal range
• Total bilirubin \>1.5 times to normal range
• e-GFR \<90 mL/min
• 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
• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Interventions

Atorvastatin; Metformin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jong-lyul Ghim, MD.PhD

  Inje University Busanpaik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share