To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers
Phase 1
- Conditions
- DyslipidemiasHypertension
- Interventions
- Combination Product: ID1803+ID1805Combination Product: ID140009
- Registration Number
- NCT05259020
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- Brief Summary
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ID1803+ID1805 ID1803+ID1805 - ID140009 ID140009 -
- Primary Outcome Measures
Name Time Method Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) 0~72hr Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax
AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) 0~72hr Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt
- Secondary Outcome Measures
Name Time Method Cmax (Free Ezetimibe) 0~72hr Free Ezetimib: Cmax
AUCt (Free Ezetimibe) 0~72hr Free Ezetimibe: AUCt
Trial Locations
- Locations (1)
H plus yangji hospital
🇰🇷Seoul, Korea, Republic of