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

NCT ID: NCT05259020

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2022-03-30

Brief Summary

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

Conditions

Dyslipidemias; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ID140009

Group Type: EXPERIMENTAL

ID140009

Intervention Type: COMBINATION_PRODUCT

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

ID1803+ID1805

Group Type: ACTIVE_COMPARATOR

ID1803+ID1805

Intervention Type: COMBINATION_PRODUCT

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

Interventions

ID140009

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

Intervention Type: COMBINATION_PRODUCT

ID1803+ID1805

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H plus yangji hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

MinJung Kim

Role: CONTACT

Phone: 025263179

Email: mjkim90@ildong.com

Facility Contacts

MinJung Kim

Role: primary

Other Identifiers

ID-VARE-104

Identifier Type: -

Identifier Source: org_study_id