Phase 1 study to evaluate the safety and the pharmacokinetics of UI061 and UIC202006 in healthy adult volunteers under fed state conditions

Not Applicable

Active, not recruiting

Conditions: Endocrine, nutritional and metabolic diseases

Registration Number: KCT0008214

Lead Sponsor: Korea United Pharm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

1) Those aged 19 years or older at the time of screening visit
2) Subjects with a weight of 50 kg or more (45 kg or more for women) and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less at the screening visit
? BMI (kg/m2) = weight (kg)/{height (m)}2
3) Those who have no clinically significant congenital or chronic diseases at the screening visit and no pathological symptoms or findings as a result of internal medical examination
4) Diagnosis tests such as hematology test, blood chemistry test, serum test, urine test, etc. and electrocardiogram test, which are set and conducted by the trial director (or the commissioned study doctor) according to the characteristics of the investigational product, and are determined to be suitable as test subjects ruler
5) From the first dose of investigational product to 7 days after the last dose of investigational product who agreed to
* Methods of contraception accepted in clinical trials: Combination of intrauterine device, vasectomy, tubal ligation and blocking contraception (male condom, female condom, cervical cap, diaphragm, sponge, etc.) Use of multiple barrier methods of contraception
Contraception Not Accepted in Clinical Trials: Hormonal Use
6) A person who voluntarily signed the consent form after receiving and understanding sufficient explanations about the purpose and contents of this clinical trial, the characteristics of the investigational product, and expected adverse reactions, etc.

Exclusion Criteria

1) Clinically significant for digestive system, cardiovascular system, endocrine system, respiratory system, blood/oncology, infectious disease, kidney and genitourinary system, mental/nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology system Those who have or have a history of a disease
2) Those with a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
3) Those who have taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month of the first administration date, or who have taken drugs that may interfere with this clinical trial within 10 days of the first administration date (except for investigational drugs) Participation possible considering pharmacokinetic and pharmacodynamic characteristics such as interaction with and half-life)
4) Those who have administered investigational drugs by participating in other clinical trials or bioequivalence studies within 6 months of the first administration date
5) Whole blood donation within 8 weeks of the first administration day, component blood donation within 2 weeks, or blood transfusion within 4 weeks
6) Those who meet the following conditions within 1 month of the first administration date
For men, average alcohol consumption exceeding 21 drinks/week
For women, average alcohol consumption exceeding 14 drinks/week
(1 glass = Soju 50mL or Western liquor 30mL or Beer 250mL)
Smoking more than 20 cigarettes per day on average
7) Those who fall under the following
Patients with hypersensitivity to this drug or the ingredients contained in this drug
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8) Patients with the following diseases
Patients with severe hepatic impairment (e.g. patients with biliary cirrhosis, active liver disease, or persistent elevation of transaminase of unknown cause (more than 3 times the upper limit of normal))
· Patients with moderate to severe renal impairment (eGFR < 60 ml/min/1.73m2)
Patients who have photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen
· Patients with gallbladder disease
Patients with acute or chronic pancreatitis due to hypertriglyceridemia
Patients with myopathy, patients with a history of rhabdomyolysis or myopathy due to statins or fibrates, and patients whose CPK level has increased more than 5 times the upper limit of normal during previous statin-based drug treatment
· Patients with interstitial lung disease
Patients with a history of pulmonary embolism
9) A person who is judged unsuitable for participation in this clinical trial by the trial director (or the entrusted trial physician) for reasons other than the above selection/exclusion criteria
10) For female volunteers, those who are pregnant or suspected of being pregnant or are breastfeeding