KCT0008214
Active, not recruiting
未知
Phase 1 study to evaluate the safety and the pharmacokinetics of UI061 and UIC202006 in healthy adult volunteers under fed state conditions
Korea United Pharm0 sites44 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Korea United Pharm
- Enrollment
- 44
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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