None listed
Conditions
Interventions
Drug : Cefepime 1 g diluted in 100 mL of 0.9% normal saline will be administered as a single intravenous infusion over 30 minutes. The intervention will be performed once on the study day, followed by
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 19 to 55 years at the time of screening - No congenital or chronic diseases and no clinically significant findings upon medical examination - Considered eligible based on screening assessments (medical history, vital signs, physical examination, hematology, blood chemistry, urinalysis, serology) - (For female subjects only) Negative urine pregnancy test
Exclusion criteria
Exclusion criteria: - Subjects with clinically significant diseases or a history thereof (including gastrointestinal, cardiovascular, respiratory, endocrine, hepatobiliary, hematologic/oncologic, musculoskeletal, renal, neurological, psychiatric, immunologic, urogenital, ophthalmologic, otorhinolaryngologic, and genetic disorders) - Subjects with a history that may affect drug absorption, distribution, metabolism, or excretion (e.g., gastrointestinal, hepatic, or renal disease) - Subjects with known hypersensitivity to cefepime or related compounds - Subjects who participated in another clinical study and received investigational products within 6 months prior to screening - Subjects with positive serology results (HBsAg, anti-HCV, HIV Ag/Ab, Syphilis) - Pregnant or breastfeeding women, or women with the potential to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration-time profile of cefepime | — |
Secondary
| Measure | Time frame |
|---|---|
| Population PK parameters and Safety assessment (Adverse events, Lab tests) | — |
Countries
Korea, Republic of
Contacts
Public ContactMiru Lee
Hallym University Medical Center
Outcome results
None listed