Drug-drug Interaction Study Between UIC201601 and UIC201602

Korea United Pharm

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: UIC201602 and co-administration of UIC201601 and UIC201602

Drug: UIC201601 and co-administration of UIC201601 and UIC201602

Study type

Interventional

Funder types

Industry

Identifiers

NCT05190133

KUP-UI018-101

Details and patient eligibility

About

An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.

Enrollment

40 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.