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

A Open-label, Single Sequence Clinical Trial to Investigate the Pharmacokinetic Characteristics of Second-Line Anti-Tuberculosis Agents After Multiple Oral/Intramuscular Administration in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02128308
Enrollment
16
Registered
2014-05-01
Start date
2013-11-30
Completion date
2014-01-31
Last updated
2014-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Antituberculosis agents, Pharmacokinetics

Brief summary

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

Interventions

DRUGLevofloxacin and Streptomycin added
DRUGMoxifloxacin and Kanamycin added

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
AUC (area under the plasma concentration-time curve)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 postdoseAUC (Area under the plasma concentration versus time curve), Cmax(maximum plasma concentration)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026