Clinical trial NCT04185090: To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults
Official title: An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Dyslipidemias
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

Detailed description: An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects

Eligibility criteria: Inclusion Criteria:

* Healthy adult male volunteers aged 19 to 45 years
* Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2
* Males must be agree to practice a medically acceptable method\* of birth control and will not donate sperm during the study.
* 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 serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
* Subject with symptoms of acute disease within 28days prior to study medication dosing
* Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
* 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: AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
timeFrame: 0~72hours
measure: Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
timeFrame: 0~72hours
Secondary outcomes:
measure: AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
timeFrame: 0~72hours
measure: Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss
timeFrame: 0~72hours
measure: Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
timeFrame: 0~72hours
measure: Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
timeFrame: 0~72hours
measure: t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
timeFrame: 0~72hours
measure: CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
timeFrame: 0~72hours
measure: Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
timeFrame: 0~72hours
measure: PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)
timeFrame: 0~72hours
Other outcomes:
Locations:
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