To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults
- Conditions
- DyslipidemiasHypertension
- Interventions
- Combination Product: ID1803Combination Product: ID1803+ID1801Combination Product: ID1801
- Registration Number
- NCT04185090
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ID1803 ID1803 qd daily for 10days Intervention: Drug: administration of ID1803 for 10days. ID1801 and ID1803 ID1803+ID1801 qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803. ID1801 ID1801 qd daily for 6days Intervention: Drug: administration of ID1801 for 6days.
- Primary Outcome Measures
Name Time Method AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe) 0~72hours Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ
Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe) 0~72hours Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss
- Secondary Outcome Measures
Name Time Method Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss 0~72hours N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss
CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) 0~72hours amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F
Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) 0~72hours amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss
Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) 0~72hours amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F
AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss 0~72hours N-desmethyl rosuvastatin, total ezetimibe: AUCτ
Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) 0~72hours amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss
t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) 0~72hours amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2
PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) 0~72hours amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF