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OpenTrials
Completed

NCT Number: NCT02185066

Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

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 and metformin XR, 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

Primary location

Inje University Busan Paik Hospital

Busan, South Korea

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 4 weeks before dosing
  • Symptom of an acute illness within 4 weeks 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
  • 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 > 5 cups/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 XR 500mg (Reference)

Drug

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

CJ-30056 20/500mg (Test)

Drug

Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.

Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.

Primary outcomes

  1. Maximum plasma concentration (Cmax) of Atorvastatin

    Time frame: Upto 36 hours

  2. Maximum plasma concentration (Cmax) of Metformin

    Time frame: Upto 24 hours

  3. Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin

    Time frame: Upto 36 hours

  4. Area Under the plasma concentration-time Curve (AUC0-t) of Metformin

    Time frame: Upto 24 hours

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of 2-OH-atorvastatin

    Time frame: Upto 36 hours

  2. Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin

    Time frame: Upto 36 hours

  3. CL/F of Atorvastatin and Metformin

    Time frame: Upto 36 hours

  4. Vd/F of Atorvastatin and Metformin

    Time frame: Upto 36 hours

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2014
Registry last updated
Dec 29, 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.

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