CKD-391 Pharmacokinetic Study Phase I

NCT02501200 | Completed Phase 1

• 1 other identifier: 152BE15026
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Dyslipidemia; CKD-391; Atorvastatin; Ezetimibe

Outcome Measures

Primary Outcomes (2)

• AUClast

  up to 96 hours post dose

• Cmax

  up to 96 hours post dose

Secondary Outcomes (4)

• Tmax

  up to 96 hours post dose

• T1/2

  up to 96 hours post dose

• AUCinf

  up to 96 hours post dose

• Adverse events

  up to 24days post dose

Study Arms (2)

TR group

EXPERIMENTAL

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

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

RT group

EXPERIMENTAL

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

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

Interventions

CKD-391 DRUG

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

RT group; TR group

Atrovastatin and Ezetimibe combination therapy DRUG

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

RT group; TR group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Choon Ok Kim, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 17, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 26, 2016

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share