KCT0008374
Completed
未知
A Phase I, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of JBPOS0101 on the Pharmacokinetics of Midazolam and the Interaction between Carbamazepine and JBPOS0101 in Healthy Subjects
Bio-Pharm Solutions0 sites16 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
- 16
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male or female volunteers at the age of 19–45 years old at screening
- •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\. A female participant who was not pregnant or breastfeeding or in infertility due to surgery with the absence of ovary and/or uterus (bilateral tubal obstruction, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.)
- •4\. Participants 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.
- •5\. Participants evaluated to be eligible by the investigator.
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\. Participants who had a hypersensitivity or allergy to MDZ and benzodiazepines or CBZ
- •5\. Participants who had any history or presence of a condition that might increase the participant risk assessed by the investigator according to the package insert of MDZ or CBZ
- •6\. Any abnormalities at screening:
- •\- AST (SGOT), ALT (SGPT) \> 1\.5 x upper limit of normal
- •\- A positive result in serum tests (Syphilis tests, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) antigen\-antibody test)
- •\- Other clinically significant abnormalities
- •7\. Participants who had a history of severe injury or planned to have a surgery within 12 weeks before screening
Outcomes
Primary Outcomes
Not specified
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