NCT03920579

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

April 8, 2019

Last Update Submit

April 17, 2019

Conditions

HypertensionDyslipidemias

Keywords

CKD-386PharmacokineticsD326D337D013

Outcome Measures

Primary Outcomes (2)

  • AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013

    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

    Cmax: Maximum plasma concentration of the drug

    0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

Secondary Outcomes (7)

  • 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

    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

    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

    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

    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

    0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

  • +2 more secondary outcomes

Study Arms (6)

Sequence 1

EXPERIMENTAL

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 1Drug: CKD-386 formulation 2Drug: D326, D337 and D013

Sequence 2

EXPERIMENTAL

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 1Drug: CKD-386 formulation 2Drug: D326, D337 and D013

Sequence 3

EXPERIMENTAL

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 1Drug: CKD-386 formulation 2Drug: D326, D337 and D013

Sequence 4

EXPERIMENTAL

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 1Drug: CKD-386 formulation 2Drug: D326, D337 and D013

Sequence 5

EXPERIMENTAL

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 1Drug: CKD-386 formulation 2Drug: D326, D337 and D013

Sequence 6

EXPERIMENTAL

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 1Drug: CKD-386 formulation 2Drug: D326, D337 and D013

Interventions

CKD-386 formulation 1DRUG

A single oral dose of 1 tablet under fasting conditions for each period

Also known as: CKD-386 Test 1
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
CKD-386 formulation 2DRUG

A single oral dose of 1 tablet under fasting conditions for each period

Also known as: CKD-386 Test 2
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
D326, D337 and D013DRUG

A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period

Also known as: CKD-386 Reference
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers aged between ≥20 and ≤45 years old
  • Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
  • Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
  • Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
  • 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

You may not qualify if:

  • 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
  • Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  • Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dongseong Shin, M.D, Ph.D

    Clinical Trials Center, Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongseong Shin, M.D, Ph.D

CONTACT

+82-32-460-9459dsshin@gilhospital.com

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

April 8, 2019

First Posted

April 19, 2019

Study Start

April 1, 2019

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)