Clinical Trial to Investigate the Pharmacokinetics of Second-Line Anti-Tuberculosis Agents

Seoul National University Hospital16 enrolled

Overview

This study aims to investigate the pharmacokinetic characteristics of second-line anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Levofloxacin and Streptomycin addedDRUG

Moxifloxacin and Kanamycin addedDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male subject aged 20 to 50 at screening * a body weight in the range of 55 kg (inclusive) to 90 kg (inclusive) with ideal body weight range of 19.0 to 26.0 subjects who decide to participate voluntarily and write a informed consent form Exclusion Criteria: * subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor * subject judged not eligible for study participation by investigator.

Locations (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUC (area under the plasma concentration-time curve)

AUC (Area under the plasma concentration versus time curve), Cmax(maximum plasma concentration)

Time frame: Predose and 2d 0h, 3d 0h, 4d 0h, and 5d 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h postdose

Data from ClinicalTrials.gov

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