A Clinical Study to Evaluate the Safety and the Pharmacokinetics of UI068 in Healthy Adult Volunteers Under Fed Conditions

NCT ID: NCT06141590

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-11
• Study Completion Date: 2023-08-29

Brief Summary

This study was open-label, randomized, fed, single-dose, 2-groups, 2 periods, crossover designe to compare the safety and pharmacokinetics of UI068 and co-administration of UIC202205 and UIC202206.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UI068

Group Type: EXPERIMENTAL

administration of UI068

Intervention Type: DRUG

Test

UIC202205, UIC202206

Group Type: EXPERIMENTAL

administration of UIC202205, UIC202206

Intervention Type: DRUG

Reference

Interventions

administration of UI068

Test

Intervention Type: DRUG

administration of UIC202205, UIC202206

Reference

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy subjects over the ages of 19 at screening
• Subjects whose body weight over 60 kg and having a body mass index (BMI) of over than 18.0 and less than 30.0 kg/m2 at screening (☞ BMI(kg/m2) = Weight(kg)/{Height(m)}2)
• There are no clinically significant congenital diseases/chronic diseases/ pathological symptoms or finding at the screening
• he principal investigator determines to be suitable test subjects as a result of diagnostic tests and electrocardiogram tests etc.
• From the date of first to the last administration of the investigational drug Until 7 weeks , tester or spouse or partner must use a method of contraception recognized in clinical trials.
• The tester who is signed after being explained and understanding about purpose and content of this clinical trial, characteristics of the investigational drug.

Exclusion Criteria

• Clinically significant diseases related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and genitourinary system, mental/nervous system, musculoskeletal system, immune system, ENT system, skin system, and ophthalmic system. Those who have or have a history of
• Those with a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
• Those who took drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month of the first dose, or took drugs that may interfere with this clinical trial within 10 days of the first dose.
• A person who participated in another clinical trial or bioequivalence test and administered an investigational drug within 6 months of the first administration date
• Those who donated whole blood or component blood within 2 weeks or received a blood transfusion within 4 weeks of the first administration date
• Those who meet the following conditions within 1 month of the first medication date

• Alcohol consumption exceeding 21 drinks/week on average for men
• For women, alcohol consumption exceeds an average of 14 drinks/week

(1 glass = 50 mL of soju or 30 mL of liquor or 250 mL of beer)

• Smoking more than 20 cigarettes per day on average
• Those who fall under the following

• Patients with hypersensitivity to clinical investigational drugs or ingredients contained in clinical investigational drugs
• Persons with a history of hypersensitivity to biguanide drugs
• Patients with the following diseases

• Patients with moderate (stage3b) and severe renal impairment (eGFR<45mL/min/1.73m2), Acute conditions that can affect kidney function, such as diabetes, serious infections, cardiovascular collapse (shock), acute myocardial infarction, and sepsis
• Patients with acute and unstable heart failure
• Patients undergoing tests requiring intravenous administration of radioiodine contrast material (e.g., intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast agent, etc.)
• Patients with acute or chronic metabolic acidosis, including type 1 diabetes, lactic acidosis, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
• Diabetic precoma
• Patients with severe infections or severe traumatic systemic disorders
• Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal dysfunction
• Patients with acute or chronic diseases that can cause tissue hypoxia such as liver dysfunction, respiratory failure, acute myocardial infarction, and shock, excessive alcohol intake, and gastrointestinal disorders such as dehydration, diarrhea, and vomiting
• For female volunteers, those who are pregnant, suspected of being pregnant, or lactating

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea United Pharm. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H plus Yangji Hospital

Seoul, Gwanak-gu, South Korea

Countries

South Korea

Other Identifiers

KUP-UI068-101

Identifier Type: -

Identifier Source: org_study_id