NCT04258865

Brief Summary

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

February 5, 2020

Last Update Submit

June 3, 2020

Conditions

HypertensionDyslipidemias

Keywords

CKD-348

Outcome Measures

Primary Outcomes (2)

  • AUCt of CKD-348

    AUCt: Area under the concentration-time curve from time zero to time

    Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

  • Cmax of CKD-348

    Cmax: Maximum plasma concentration of the drug

    Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Secondary Outcomes (4)

  • AUCinf of CKD-348

    Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

  • Tmax of CKD-348

    Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

  • t1/2 of CKD-348

    Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

  • AUCt/AUCinf of CKD-348

    Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Study Arms (6)

Sequence 1

EXPERIMENTAL

Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions

Drug: CKD-348 F1Drug: CKD-348 F2Drug: CKD-828, D097, D337

Sequence 2

EXPERIMENTAL

Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions

Drug: CKD-348 F1Drug: CKD-348 F2Drug: CKD-828, D097, D337

Sequence 3

EXPERIMENTAL

Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions

Drug: CKD-348 F1Drug: CKD-348 F2Drug: CKD-828, D097, D337

Sequence 4

EXPERIMENTAL

Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions

Drug: CKD-348 F1Drug: CKD-348 F2Drug: CKD-828, D097, D337

Sequence 5

EXPERIMENTAL

Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions

Drug: CKD-348 F1Drug: CKD-348 F2Drug: CKD-828, D097, D337

Sequence 6

EXPERIMENTAL

Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions

Drug: CKD-348 F1Drug: CKD-348 F2Drug: CKD-828, D097, D337

Interventions

CKD-348 F1DRUG

QD, PO

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
CKD-348 F2DRUG

QD, PO

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
CKD-828, D097, D337DRUG

QD, PO

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult volunteers aged ≥ 19-year-old
  • Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
  • Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
  • Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
  • Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
  • Those who agree to contraception during the participation of clinical trial
  • 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:

  • Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
  • Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
  • Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
  • Those who has a history of gastrointestinal surgery (
  • Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
  • Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
  • 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
  • Women who are pregnant or who may be pregnant and breastfeed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yook-Hwan Noh, M.D., PhD.

    H Plus Yangji 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

February 5, 2020

First Posted

February 6, 2020

Study Start

March 25, 2020

Primary Completion

April 26, 2020

Study Completion

May 13, 2020

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

KR(1)