None listed
Conditions
Interventions
Drug : AGM-130, 100 ug, single dose, intravenous bolus injection
Sponsors
AnyGen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male Korean subject age 19 to 45 at the screening visit 2. Subject who is over 55kg and as a result of calculated Ideal Body Weight, subject who is within the range of ±20% 3. After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
Exclusion criteria
Exclusion criteria: 1. history or clinical manifestation of clinically significant cardiovascular, respiratory, renal, endocrine, hematologic, digestive, central nervous, psychiatric disorder or malignant tumor; 2. history of gastrointestinal tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of fluconazole and omeprazole 3. significant hypersensitive or clinically significant hypersensitivity reactions to any drug compound or other azole medicines or additives 4. determined as not appropriate for study participant during healthy examination (medical history, physical exam, lab test, vital sign) at screening 5. history of drugs abuse 6. consumption of excessive caffeine, alcohol, and cigarette (caffeine: 5 cups/day, alcohol: 210g/week, cigarette: >10/day) 7 use of other clinical trial's investigational drug within 90 days prior to investigational study drug administration 8. use of drug metabolizing enzyme inducers or inhibitors such as barbiturates within 30 days prior to investigational study drug administration 9. donation of blood from 60 days or plasma from 30 days prior to investigational study drug administration 10. consumption of grapefruit-containing foods and beverages within 7 days prior to investigational study drug administration 11. use of any prescription medicines or herbal medicines within 14 days prior to investigational study drug administration or over-the-counter or vitamin preparations within 7 days before prior to investigational study drug administration 12. ineligible for participation in clinical trials due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUClast | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf | — |
Countries
Korea, Republic of
Contacts
Public ContactWan-Su Park
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed