NCT05749861

Brief Summary

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(5).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2023

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

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 22, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

February 20, 2023

Last Update Submit

January 22, 2024

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • AUCt of CKD-348(5)

    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(5)

    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

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(5) - 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 Period 4: CKD-348(5) - A single oral dose of 1 tablet under fasting condition

Drug: CKD-348(5)Drug: CKD-828, D097, D337

Sequence 2

EXPERIMENTAL

Period 1: CKD-348(5) - 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(5) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition

Drug: CKD-348(5)Drug: CKD-828, D097, D337

Interventions

CKD-348(5)DRUG

QD, PO

Sequence 1Sequence 2
CKD-828, D097, D337DRUG

QD, PO

Sequence 1Sequence 2

Eligibility Criteria

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

You may qualify if:

  • Healthy adult volunteers aged ≥ 19 years.
  • Body 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 ECG results at screening.
  • 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 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

    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 20, 2023

First Posted

March 1, 2023

Study Start

April 22, 2023

Primary Completion

June 7, 2023

Study Completion

July 18, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

KR(1)