None listed
Conditions
Interventions
Drug : ? Investigational Products
E: eperisone 50 mg (Murex Tab. 50 mg/tab, Chong Kun Dang Pharmaceutical Corp.)
O: ojeoksan (Hanpoong Ojeoksan Soft Extract 15.0 g/packet, Hanpoong Pharm Co., Ltd.)
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged between 19 and 55 years at screening. 2) Body weight 55 kg or over for men and 50 kg or over for women. 3) Body mass index (BMI) more than 18.5 kg/m2 and less than 27.0 kg/m2. ? BMI (kg/m2)= body weight (kg)/[height (m)]2 4) If female, one of the following criteria must be met: - Postmenopausal (no natural menstruation for at least 2 years) - Surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation, or other methods of sterility) 5)If male and engaging in sexual activity with a woman of childbearing potential, must agree to use the following contraceptive methods* during the study and for at least 28 days after the last dose of the investigational medicinal product, and must not donate sperm *Contraceptive methods: Combination of vasectomy, intrauterine device (IUD), tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) used together, or if using spermicides, at least two barrier methods used together.
Exclusion criteria
Exclusion criteria: 1) Individuals with clinically significant diseases or histories related to the hepatobiliary system (e.g., severe liver disorders), renal system (e.g., severe renal impairment), cardiovascular system (e.g., uncontrolled hypertension, heart failure), immune system, nervous system (e.g., severe myasthenia gravis), urogenital system, digestive system, endocrine system, hematology/oncology, or mental disorders. 2) Individuals with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis) or surgeries that could affect drug absorption (except for simple appendectomy or hernia surgery). 3) Individuals with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 4) Individuals with a significant history of drug hypersensitivity to the components or excipients of the IP. 5) Individuals deemed unsuitable for the study based on screening tests conducted within 28 days before the first administration of the IP: - Blood AST or ALT levels > 1.5 times the upper limit of normal - eGFR (estimated Glomerular Filtration Rate) 150 mmHg or 100 mmHg or 5 cups/day, alcohol: > 210 g/week, smoking: > 10 cigarettes/day) or who cannot abstain from smoking, caffeine, and alcohol during each hospitalization period. 8) Individuals who have consumed grapefruit-containing foods within 7 days before the first administration of the IP or cannot abstain from them during the study period. 9) Individuals who have participated in another study and received an IP within 180 days before the first administration of the IP (this period may be extended for biological products considering their half-lives). 10) Individuals who have donated whole blood within 60 days or component blood within 30 days before the first administration of the IP. 11) Individuals who have received a blood transfusion within 30 days before the first administration of the IP. 12) Pregnant or breastfeeding women. 13) Individuals deemed unsuitable for study participation by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUClast of eperisone and ephedrine | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, t1/2, Vd/F, CL/F of eperisone and ephedrine | — |
Countries
Korea, Republic of
Contacts
Public ContactChoon Ok Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed