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CompletedNCT02461004Updated Oct 17, 2016

CKD-391 Pharmacokinetic Study

A Phase 1 interventional study of CKD-391 and Atrovastatin and Ezetimibe combination therapy in Healthy, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Dyslipidemia
  • CKD-391
  • Atorvastatin
  • Ezetimibe
03

In context

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Bwt >=50kg, BMI 18\~29
  • signed the informed consent form prior to the study participation

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    TR group

    CKD-391 and combination dose of Atrovastatin and Ezetimibe in order

    Drug: CKD-391 · Drug: Atrovastatin and Ezetimibe combination therapy

  • Experimental
    RT group

    combination dose of Atrovastatin and Ezetimibe and CKD-391 in order

    Drug: CKD-391 · Drug: Atrovastatin and Ezetimibe combination therapy

Interventions

  • DrugCKD-391

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

  • DrugAtrovastatin and Ezetimibe combination therapy

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

06

What researchers measure

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

07

Study locations

1 site
  • The Korea University Anam Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02461004
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jun 3, 2015
Start date
Jul 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Oct 17, 2016

Study contacts

Ji Young Park, Ph.D.
principal investigator · The Korea University Anam Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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