KCT0008718
Completed
未知
An open-label, single-dose, phase 1 clinical trial to investigate the absorption, metabolism and excretion of JBPOS0101 after oral administration of JBPOS0101 600 mg and 14C-labeled JBPOS0101 at a microdose in healthy adults
Bio-Pharm Solutions0 sites6 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Bio-Pharm Solutions
- Enrollment
- 6
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male or female adults at the age of 19\-50 years old at the time of informed consent
- •2\. Body weight \= 50\.0 kg and body mass index (BMI) within the range of 19\.0–30\.0 kg/m2 at screening
- •? BMI \= Body weight (kg)/(Height \[m])2
- •3\. Subjects who voluntarily decided to participate in the study after receiving and fully understanding detailed information on the study and provided written informed consent to comply with study instructions before the screening procedure
- •4\. Subjects who are evaluated to be eligible by the investigator when assessed by physical examination, clinical laboratory tests, questionnaire, etc
Exclusion Criteria
- •1\. Participants who had a clinically significant disease or history in hepatic, renal, neurological, immunologic, respiratory (sleep apnea syndrome, acute respiratory failure), metabolic disease or hemato\-oncology, cardiovascular disease (heart failure, myocardial infarction), psychiatric disease (mood disorder, obsessive\-compulsive disorder, etc.)
- •2\. Participants who had any history or presence of a gastrointestinal disease (gastrointestinal ulcer, gastritis, gastric cramp, gastro\-esophageal reflux disease, Crohn’s disease, etc.) which may affect the safety and PK/pharmacodynamics (PD) of the IP and any history of surgery in gastrointestinal system (except for simple appendectomy or herniotomy)
- •3\. Participants who had any history of clinically significant hypersensitivity (including status asthmaticus, anaphylaxis, Stevens\-Johnson syndrome, toxic epidermal necrolysis, etc.) to drugs associated with the IP or food assessed by the investigators
- •4\. Subjects who have been exposed to radiation that exceeds the annual allowable effective dose limit (1 mSv (100 mrem)) for the general public within 1 year from the Screening or who may exceed the annual effective dose limit when administering this investigational product
- •5\. Subjects who have worked in the field of radiation workers within 1 year prior to Screening, or who have experienced existing and planned exposure situations for the general public as defined by the ICRP as below.
- •\[Existing exposure situation]
- •Contamination of the area by residual radioactive materials originating from past nuclear facility operations, nuclear or radiation emergencies
- •Residual contamination from activities previously subject to regulatory control that are not under current requirements
- •Use of consumer goods such as food, drinking water, and building materials that contain natural or residual artificial radionuclides
- •Exposure to indoor natural sources, including radon
Outcomes
Primary Outcomes
Not specified
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