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Completed

NCT Number: NCT02501200

CKD-391 Pharmacokinetic Study Phase I

A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

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Key information

Conditions

Healthy Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.

Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Bwt >=50kg, BMI 18.5~25
  • signed the informed consent form prior to the study participation

Exclusion criteria

  • - Clinically significant disease
  • Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
  • Clinically significant allergic disease
  • Impossible to taking the institutional standard meal
  • Previously donate whole blood within 60 days or component blood within 20 days
  • Previously participated in other trial within 90 days
  • Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Treatment and study plan

CKD-391

Drug

Investigational product is prescribed to all of randomized subjects for two times.

Atrovastatin and Ezetimibe combination therapy

Drug

Investigational products are prescribed to all of radomized subjects for two times.

Primary outcomes

  1. AUClast

    Time frame: up to 96 hours post dose

  2. Cmax

    Time frame: up to 96 hours post dose

Secondary outcomes

  1. Tmax

    Time frame: up to 96 hours post dose

  2. T1/2

    Time frame: up to 96 hours post dose

  3. AUCinf

    Time frame: up to 96 hours post dose

  4. Adverse events

    Time frame: up to 24days post dose

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2015
Registry last updated
Dec 26, 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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