Status:
UNKNOWN
To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers
Lead Sponsor:
IlDong Pharmaceutical Co Ltd
Conditions:
Dyslipidemias
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05259020
Start Date
February 22 2022
End Date
March 30 2022
Last Update
February 28 2022
Active Locations (1)
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1
H plus yangji hospital
Seoul, South Korea