A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers

Korábbi kezelés

• Subjects with hereditary angioedema or a history of angioedema during treatment with an ACE inhibitor or an angiotensin II receptor blocker.
• Subjects who have taken enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 1 month before the first administration, or who have taken medications that may interfere with this clinical trial within 10 days before the first administration (however, participation may be allowed after considering pharmacokinetic and pharmacodynamic characteristics such as interactions with the investigational product and drug half-life).
• Subjects who have consumed grapefruit-containing foods within 7 days before the first administration or who are unable to refrain from consuming such foods during the clinical trial.
• Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months before the first administration.
• Subjects who have donated whole blood within 8 weeks before the first administration, donated blood components within 2 weeks, or received a blood transfusion within 4 weeks.
• Subjects who meet any of the following conditions within 1 month before the first administration.
  • Average alcohol consumption exceeding 21 drinks/week for males.
  • Average alcohol consumption exceeding 14 drinks/week for females.
  • (1 drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer.)
  • Smoking more than 10 cigarettes per day on average.

Más betegség

• Subjects with current or past history of clinically significant diseases involving the renal system (e.g., severe renal impairment), nervous system (e.g., cerebrovascular disease), immune system, respiratory system (e.g., bronchial asthma), urinary system, gastrointestinal system, endocrine system (e.g., congenital lipid metabolism disorders, severe diabetes mellitus), hematologic/oncologic system, cardiovascular system (e.g., severe hypertension, heart failure, coronary artery disease), reproductive system (e.g., endometrial hyperplasia, endometriosis), psychiatric disorders, or myopathy.
• Subjects with a history of gastrointestinal surgery (except simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal disease.
• Subjects with active liver disease or persistent elevation of aminotransferase levels of unknown cause.
• Subjects with a history of drug abuse within 1 year before screening or those with a positive urine drug screening test.

Laborértékek

• Subjects with severe hepatic impairment, biliary obstruction, or cholestasis (this drug is excreted almost entirely via bile. Cholestasis, biliary obstructive disease, or hepatic impairment may be expected to reduce hepatic clearance.).
• Subjects considered unsuitable for participation based on screening assessments performed within 30 days before the first administration of the investigational product.
  • AST or ALT > 1.5 × the upper limit of the normal range.
  • Total bilirubin > 1.5 × the upper limit of the normal range.
  • eGFR (estimated Glomerular Filtration Rate), calculated using the MDRD (Modification of Diet in Renal Disease) equation, < 60 mL/min/1.73m².
  • Positive results for serologic tests (hepatitis B, hepatitis C, human immunodeficiency virus [HIV], or syphilis).
  • After at least 5 minutes of rest, seated vital signs showing systolic blood pressure > 139 mmHg or < 100 mmHg, or diastolic blood pressure > 90 mmHg or < 60 mmHg.
• Subjects who meet any of the following conditions.
  • Subjects with hypersensitivity to this drug or any of its components.
  • Subjects with hereditary problems of fructose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Egyéb

• Subjects whom the Investigator (or delegated Sub-investigator) considers unsuitable for participation in this clinical trial for reasons other than the above inclusion/exclusion criteria (e.g., excessive tattoos).
• Female subjects who are pregnant, suspected to be pregnant, or breastfeeding.

• Subjects aged 19 years or older and less than 55 years at the screening visit.
• Subjects with a body weight of at least 50 kg (at least 45 kg for females) and a body mass index (BMI) of 18.0 kg/m² or higher and 30.0 kg/m² or lower at the screening visit.
  • BMI (kg/m²) = Body weight (kg) / Height (m)²
• Subjects who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examination at the screening visit.
• Subjects determined to be eligible for participation in the clinical trial by the Investigator (or delegated Sub-investigator) based on the evaluation results of hematology, blood chemistry, serology, urinalysis, other clinical laboratory tests, physical examination, and electrocardiogram (ECG), which are established and performed according to the characteristics of the investigational product.
• Subjects who agree that they and/or their spouse or partner will use highly effective contraception (excluding hormonal contraceptives) from the first administration of the investigational product until 14 days after the last administration to prevent pregnancy and who agree not to donate sperm or ova.
  • Highly effective methods of contraception: intrauterine device (IUD), bilateral tubal occlusion, vasectomized partner, sexual abstinence.
• Subjects who have received and understood sufficient explanation regarding the purpose, procedures, characteristics of the investigational product, and anticipated adverse events of this clinical trial, and who have voluntarily signed the informed consent form.