NCT05259020

Brief Summary

To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult 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
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

February 17, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

February 17, 2022

Last Update Submit

February 17, 2022

Conditions

DyslipidemiasHypertension

Outcome Measures

Primary Outcomes (2)

  • AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)

    Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt

    0~72hr

  • Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)

    Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax

    0~72hr

Secondary Outcomes (2)

  • AUCt (Free Ezetimibe)

    0~72hr

  • Cmax (Free Ezetimibe)

    0~72hr

Study Arms (2)

ID140009

EXPERIMENTAL
Combination Product: ID140009

ID1803+ID1805

ACTIVE COMPARATOR
Combination Product: ID1803+ID1805

Interventions

ID140009COMBINATION_PRODUCT

Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg

ID140009
ID1803+ID1805COMBINATION_PRODUCT

(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)

ID1803+ID1805

Eligibility Criteria

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

You may qualify if:

  • Healthy adult volunteers aged over 19 years
  • Subjects who have over 50kg and BMI more than 18.5kg/m\^2 and less than 29.9kg/m\^2
  • Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.
  • Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.
  • Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period

You may not qualify if:

  • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
  • History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug
  • Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
  • Subject with symptoms of acute disease within 28days prior to study medication dosing
  • Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
  • Subject with a history of drug abuse or urinalysis positive
  • Subject with clinically significant active chronic disease
  • Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
  • Genetic myopathic disorder or related family history
  • Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
  • Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
  • Subject who cannot take standard meal in hospitalization
  • Present history of hypothyroidism or clinically significant assay
  • Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
  • Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H plus yangji hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

DyslipidemiasHypertension

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

MinJung Kim

CONTACT

025263179mjkim90@ildong.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

February 17, 2022

First Posted

February 28, 2022

Study Start

February 22, 2022

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

KR(1)