None listed
Conditions
Interventions
Drug : Study drug: Vancomycin
Dose: 500mg, Single-dose
Rout: I.V.
Single-arm
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects aged between 19 and 65 (inclusive) at screening 2) Subjects who have a body mass index greater than 14 4 kg/m2 (inclusive) and less than 18.5 kg/m2 (not inclusive) 3) If female, the subject should not be pregnant or breastfeeding, or the subject should have undergone sterilization operation. 4) Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol 5) Clinically confirmed as eligible to participate in this study based on physical examination, clnical laboratory tests, medical history
Exclusion criteria
Exclusion criteria: 1) Current or history of a clinically significant hepatic (severe hepatic impairment), renal (severe renal impairment), neurological, immune, respiratory, gastrointestinal, endocrine, hemato-oncological, cardiovascular (heart failure, Torsades de pointes, etc.), urological, psychiatric disease 2) Subjects with any of the following conditions - history of shock due to vancomycin - history of hypersensitivity due to vancomycin, peptide antibiotics, or aminoglycoside antibiotics - history of hearing disorder due to peptide antibiotics or aminoglycoside antibiotics - history of vestibular organ or cochlear damage 3) Subjects with any of the following results at the time of screening - serum AST (SGOT), ALT (SGPT), T.bil, ALP: > ULN x 2.0 - eGFR using CKD-EPI equation: 150 mmHg, or diastolic blood pressure 100 mmHg at a sitting position with more than 3 min of resting 5) Subjects who plan to become pregnant or who refused to use birth control methods that are considered to be highly effective until 30 days after dosing (e.g., sterilization operation of the subject or the subject's partner, insertion of a contraceptive device, barrier methods (diaphragm or condom) 6) Participated in another bioequivalence study or clinical study and have been exposed to an investigational product within 6 months prior to the date of the first dose of this study 7) Donated whole blood within 2 months or blood components within 1 month, or received a blood transfusion within 1 month prior to the date of the first dose of this study 8) Subjects who can not quit drinking during admission 9) Subjects who can not quit smoking during admission 10) Positive results in serology tests (hepatitis B tests, human immunodeficiency virus [HIV] tests, hepatitis C tests, or syphilis tests [RPR]) 11) Determined inappropriate for the study based on including but not limited to clinical laboratory tests, physical examination, electrocardiogram results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax , AUClast, AUCinf, Tmax, t1/2, CL, Vz of Vancomycin | — |
Secondary
| Measure | Time frame |
|---|---|
| Bioelectric Impedance Analysis | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Won Lee
Hanyang University Seoul Hospital
Outcome results
None listed