A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

April 17, 2019 updated by: Chong Kun Dang Pharmaceutical

A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy volunteers aged between ≥20 and ≤45 years old
  2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
  3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
  4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
  5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

  1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
  2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 1
Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 2
Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Names:
  • CKD-386 Reference
Experimental: Sequence 2
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 1
Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 2
Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Names:
  • CKD-386 Reference
Experimental: Sequence 3
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 1
Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 2
Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Names:
  • CKD-386 Reference
Experimental: Sequence 4
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 1
Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 2
Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Names:
  • CKD-386 Reference
Experimental: Sequence 5
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 1
Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 2
Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Names:
  • CKD-386 Reference
Experimental: Sequence 6
Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 1
Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Names:
  • CKD-386 Test 2
Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Names:
  • CKD-386 Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t: Area under the concentration-time curve from time zero to time
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax: Maximum plasma concentration of the drug
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
AUCinf: Area under the concentration-time curve from zero up to ∞
0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Tmax: Time to maximum plasma concentration
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
t1/2: Terminal elimination half-life
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
CL/F: Apparent total body clearance of the drug
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Vd/F: Apparent volume of distribution
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t: Area under the concentration-time curve from time zero to time
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax: Maximum plasma concentration of the drug
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Dongseong Shin, M.D, Ph.D, Clinical Trials Center, Gil Medical Center, Incheon, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183PK18034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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