To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over, Clinical Trial to Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers.

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

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Combination product: ID140009; Combination product: ID1803+ID1805

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: MinJung Kim; Phone Number: 025263179; Email: mjkim90@ildong.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • H Plus Yangji Hospital
    • Contact: MinJung Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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
  • Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
  • Subjects who judged ineligible by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ID140009	Combination product: ID140009; Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg
Active Comparator: ID1803+ID1805	Combination product: ID1803+ID1805; (Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt (Free Ezetimibe)	Free Ezetimibe: AUCt	0~72hr
Cmax (Free Ezetimibe)	Free Ezetimib: Cmax	0~72hr

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): February 22, 2022
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: ID-VARE-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No