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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259020
• Other study ID #: ID-VARE-104
• Status: Recruiting
• Phase: Phase 1
• Start date: February 22, 2022
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2022
• Source: IlDong Pharmaceutical Co Ltd
• Contact: MinJung Kim
• Phone: 025263179
• Email: mjkim90[@]ildong.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Combination Product:
• ID140009
Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg
• ID1803+ID1805
(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)

Locations

Country	Name	City	State
Korea, Republic of	H plus yangji hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)	Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt	0~72hr
Primary	Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)	Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax	0~72hr
Secondary	AUCt (Free Ezetimibe)	Free Ezetimibe: AUCt	0~72hr
Secondary	Cmax (Free Ezetimibe)	Free Ezetimib: Cmax	0~72hr