A Phase 1, 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

Not Applicable

Completed

• Conditions: Diseases of the nervous system

• Registration Number: KCT0008374
• Lead Sponsor: Bio-Pharm Solutions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-30
• Last Update Posted: 2 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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
8. Participants who had a history of suicidal behavior and/or ongoing suicidal ideation as assessed by the C-SSRS
9. Participants who had a history of drug abuse or a positive result for drugs with abuse potential in the urine drug test at screening
10. Participants who had a past or planned treatment with any prescription drugs or herbal medicine within 2 weeks, or any over the counter drugs, health functional foods, or vitamin supplements within 1 week prior to the first IP administration day (individual who was eligible based on other criteria may participate in the study at the discretion of the investigator)
11. Participants who had taken an inducer or inhibitor of any drug metabolic enzyme such as barbiturates, etc. within 1 month prior to the first IP administration day
12. Participants who had participated in any other clinical study (including bioequivalence study) within 6 months prior to the first IP administration day
13. Participants who donated the whole blood within 2 months or the component blood within 1 month, or those who received the blood transfusion within 1 month prior to the first IP administration day
14. Participants who continuously consumed alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) within 1 month prior to the first IP administration day or were not able to avoid drinking during the study period from 3 days prior to the first IP administration day
15. Current smokers (individuals who stopped smoking at least 3 months prior to the first IP administration day could be included.) or participants who were not able to stop smoking during the study period at least 3 months prior to the first IP administration day
16. Participants who were not able to avoid consuming grapefruit-containing food during the study period from 7 days prior to the first IP administration day
17. Par

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort A : Cmax, AUClast, AUCinf of Midazolam / Cohort B : Cmax,ss, AUCt,ss of Carbamazepine and JBPOS0101

Secondary Outcome Measures

Name	Time	Method
Cohort A : Tmax, t1/2, CL, Vz of Midazolam and Tmax, Cmax, AUClast, AUCinf, t1/2, MR of 1-hydroxy Midazolam / Cohort B : Tmax,ss, AUClast, AUCinf, t1/2,ss, CLss/F, Vz,ss/F of Carbamazepine and JBPOS0101;Safety Evaluation (AEs, Physical Examination, Vital signs, Oxygen saturation, 12-lead ECG, Clinical laboratory tests, C-SSRS, OAA/S)