NCT05549401

Brief Summary

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_1

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

September 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

September 18, 2022

Last Update Submit

June 7, 2023

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • AUCt of CKD-348(4) F1 and CKD-348(4) F2

    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(4) F1 and CKD-348(4) F2

    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

Study Arms (6)

Sequence 1

EXPERIMENTAL

Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition

Drug: CKD-348(4) F1Drug: CKD-348(4) F2Drug: CKD-828, D097, D337

Sequence 2

EXPERIMENTAL

Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition

Drug: CKD-348(4) F1Drug: CKD-348(4) F2Drug: CKD-828, D097, D337

Sequence 3

EXPERIMENTAL

Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition

Drug: CKD-348(4) F1Drug: CKD-348(4) F2Drug: CKD-828, D097, D337

Sequence 4

EXPERIMENTAL

Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition

Drug: CKD-348(4) F1Drug: CKD-348(4) F2Drug: CKD-828, D097, D337

Sequence 5

EXPERIMENTAL

Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition

Drug: CKD-348(4) F1Drug: CKD-348(4) F2Drug: CKD-828, D097, D337

Sequence 6

EXPERIMENTAL

Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition

Drug: CKD-348(4) F1Drug: CKD-348(4) F2Drug: CKD-828, D097, D337

Interventions

CKD-348(4) F1DRUG

QD, PQ

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

QD, PQ

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

QD, PQ

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

Eligibility Criteria

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

You may qualify if:

  • Healthy adult volunteers aged ≥ 19 years
  • Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
  • Those who meet the 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 diseases or chronic diseases and have no abnormal symptoms or findings.
  • Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 1ECG results at screening.
  • Those who agree to contraception during the participation of clinical trial.
  • Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

You may not qualify if:

  • Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
  • Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
  • Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
  • Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
  • Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
  • Alcohol: Man - 21 glasses/week Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
  • Smoking: 20 cigarettes/day
  • Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
  • Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
  • Those who are deemed insufficient to participate in this clinical trial by investigators.
  • Woman who are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H plus Yangji hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jaewoo Kim, M.D. Ph.D

    m3116@newyjh.com

    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

September 18, 2022

First Posted

September 22, 2022

Study Start

September 29, 2022

Primary Completion

November 30, 2022

Study Completion

December 9, 2022

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

KR(1)