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CKD-391 Pharmacokinetic Study Phase I

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ClinicalTrials.gov Identifier: NCT02501200
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Healthy Drug: CKD-391 Drug: Atrovastatin and Ezetimibe combination therapy Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arm Intervention/treatment
Experimental: TR group
CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
Drug: CKD-391
Investigational product is prescribed to all of randomized subjects for two times.

Drug: Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.

Experimental: RT group
combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
Drug: CKD-391
Investigational product is prescribed to all of randomized subjects for two times.

Drug: Atrovastatin and Ezetimibe combination therapy
Investigational products are prescribed to all of radomized subjects for two times.




Primary Outcome Measures :
  1. AUClast [ Time Frame: up to 96 hours post dose ]
  2. Cmax [ Time Frame: up to 96 hours post dose ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501200


Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Choon Ok Kim, Ph.D Severance Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02501200    
Other Study ID Numbers: 152BE15026
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Dyslipidemia
CKD-391
Atorvastatin
Ezetimibe
Additional relevant MeSH terms:
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Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents