KCT0008216
Recruiting
未知
Phase 1 study to evaluate the food effect on the safety and the pharmacokinetics of UI061 in he althy volunteers
Korea United Pharm0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Korea United Pharm
- Enrollment
- 24
- Status
- 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\) Those who weighed more than 60 kg and had 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 and no pathological symptoms or findings as a result of internal medical examination at the screening visit
- •4\) Those who are determined to be suitable by diagnosis tests such as hematology test, blood chemistry test, serum test, urine test, etc. and electrocardiogram test, which are set and conducted by the principal investigator (or the delegated sub\-investigator)
- •5\) From the first administration of the investigational product until 7 weeks after the last administration of the investigational products, the person, spouse, or partner agrees to exclude the possibility of pregnancy by using a contraceptive method\* recognized in clinical trials and does not provide sperm or eggs who agreed to
- •\* Recognized methods of contraception in clinical trials: Combination of intrauterine device, vasectomy, tubal ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or two methods when using spermicide Use of multiple barrier methods of contraception
- •6\) Those who voluntarily signed a written informed 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\) Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
- •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 drug metabolism enzymes, such as barbiturate drugs, within one month of the first administration date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
- •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\) A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a 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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