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

Sponsor

IlDong Pharmaceutical Co Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05259020

Collaborator

(none)

Enrollment

Location

Arms

1.2

Anticipated Duration (Months)

50.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias Hypertension	Combination Product: ID140009 Combination Product: ID1803+ID1805	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Anticipated Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) [0~72hr]
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt
Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) [0~72hr]
Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax

Secondary Outcome Measures

AUCt (Free Ezetimibe) [0~72hr]
Free Ezetimibe: AUCt
Cmax (Free Ezetimibe) [0~72hr]
Free Ezetimib: Cmax

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H plus yangji hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

IlDong Pharmaceutical Co Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IlDong Pharmaceutical Co Ltd

ClinicalTrials.gov Identifier:

NCT05259020

Other Study ID Numbers:

ID-VARE-104

First Posted:

Feb 28, 2022

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyslipidemias

Study Results

No Results Posted as of Feb 28, 2022