None listed
Conditions
Interventions
Drug : Investigational Products
• P: pregabalin 150 mg (Lyrica® capsules 150 mg, Viatris Korea Co., Ltd.)
• A1: Gamisoyosan (Krasie Kami-shoyo-san Extract Granules, KBPharm Inc.)
• A2: Huang Lian Jie
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 19 to 55 years at the time of screening. 2) Body weight =55 kg for males, and =50 kg for females. 3) Body mass index (BMI) =18.5 kg/m² and <27.0 kg/m². ? BMI (kg/m²) = weight (kg) / [height (m)]² 4) If female, must meet at least one of the following: - Postmenopausal (no natural menses for at least 2 years) - Surgically sterile (history of hysterectomy, bilateral oophorectomy, tubal ligation, or other methods leading to infertility) 5) If male and sexually active with a woman of childbearing potential, must agree to use acceptable contraception* and not donate sperm throughout the study and for at least 10 weeks after the last administration of the investigational medicinal product (IMP). *Acceptable contraception methods include vasectomy, intrauterine device (IUD), tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge). If spermicides are used, at least two barrier methods must be combined. 6) Willing and able to provide written informed consent after receiving a full explanation of the study and agreeing to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1) History or presence of clinically significant diseases of the hepatobiliary system (e.g., severe hepatic impairment), renal system (e.g., severe renal impairment), cardiovascular system (e.g., uncontrolled hypertension, heart failure), immune system, nervous system (e.g., severe myasthenia), genitourinary system, gastrointestinal system, endocrine system, hematologic/oncologic disorders, or psychiatric disorders. 2) Lifetime history of suicide attempt, or suicidal ideation within 6 months prior to the first administration of the investigational medicinal product (IMP). 3) History of gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis) or surgery that may affect drug absorption (except simple appendectomy or hernia repair). 4) Known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 5) History of clinically significant hypersensitivity to pregabalin or any excipients of the IMP. 6) History of drug dependence or abuse. 7) Any of the following laboratory or clinical findings at screening (within 28 days before first dosing) considered unsuitable for participation: - AST or ALT >1.5 × upper limit of normal (ULN) - Total bilirubin >1.5 × ULN - Creatine phosphokinase (CPK) >2.0 × ULN - eGFR 150 mmHg or 100 mmHg or 5 cups/day - Alcohol >210 g/week - Tobacco >10 cigarettes/day 10) Consumption of grapefruit-containing foods within 7 days before first dosing or inability to abstain during the study period. 11) Participation in another clinical trial and exposure to an IMP within 180 days prior to first dosing (longer if required based on the half-life of a biologic agent). 12) Whole blood donation within 60 days or component blood donation within 30 days prior to first dosing. 13) Receipt of a blood transfusion within 30 days prior to first dosing. 14) Pregnant or breastfeeding women. 15) Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss and AUCtau,ss of pregabalin | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf,ss Tmax,ss, t1/2, Vd/F, and CL/F of pregabalin | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung Hoon Mo
Yonsei University Health System, Severance Hospital
Outcome results
None listed