Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05190133
Eligibility Criteria:
Inclusion Criteria:
* Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
* Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
* Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
* Subjects able to read and understand a written informed consent, and willing to participate in the study.
Exclusion Criteria:
* Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
* Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
* Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
* Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
* Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
* etc.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT05190133
Study Brief:
Protocol Section:
NCT05190133