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OpenTrials
Completed

NCT Number: NCT02378441

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

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • Donated blood within 60 days prior to dosing
  • Participated in a previous clinical trial within 60 days prior to dosing
  • Use of any other medication, including herbal products, within 10 days before dosing
  • Subjects considered as unsuitable based on medical judgement by investigators

Treatment and study plan

Atorvastatin 20mg and Metformin SR 750mg

Drug

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

Other names: Atorvastatin (Lipitor) and Metformin (Glucophage SR)

CJ-30056 20/750mg

Drug

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

Other names: not yet approved

Primary outcomes

  1. Maximum plasma concentration (Cmax) of Atorvastatin and Metformin

    Time frame: Up to 32 hours

Secondary outcomes

  1. Area under the curve(AUC) of Atorvastatin and Metformin

    Time frame: Up to 32 hours

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Dec 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.