Clinical trial NCT05259020: To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dyslipidemias
Hypertension
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
timeFrame: 0~72hr
measure: Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine)
timeFrame: 0~72hr
Secondary outcomes:
measure: AUCt (Free Ezetimibe)
timeFrame: 0~72hr
measure: Cmax (Free Ezetimibe)
timeFrame: 0~72hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H plus yangji hospital
Study officials:
References: