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CompletedNCT02128308Updated May 1, 2014

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

A Phase 1 interventional study of Levofloxacin and Streptomycin added and Moxifloxacin and Kanamycin added in Healthy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-01.

Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy

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Keywords

  • Antituberculosis agents
  • Pharmacokinetics
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 16 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Levofloxacin and Streptomycin added

    Levofloxacin and Streptomycin added : Cycloserine(CS) 250mg bid, P-aminosalicylic acid(PAS) 2 pack bid, Prothionamide(PTH) 250mg (125mg x 2 tab) bid, Pyrazinamide(PZA) 1500mg (500mg x 3 tab) qd, Levofloxacin 750mg (500mg x 1.5 tab) qd, Streptomycin 1g IM qd

    Drug: Levofloxacin and Streptomycin added

  • Experimental
    Moxifloxacin and Kanamycin added

    Cycloserine(CS) 250mg bid, P-aminosalicylic acid(PAS) 2 pack bid, Prothionamide(PTH) 250mg (125mg x 2 tab) bid, Pyrazinamide(PZA) 1500mg (500mg x 3 tab) qd, Moxifloxacin 400mg (400mg x 1 tab) qd, Kanamycin 1g IM qd

    Drug: Moxifloxacin and Kanamycin added

Interventions

  • DrugLevofloxacin and Streptomycin added

    Also known as: Cycloserine, P-aminosalicylic acid, Prothionamide, Pyrazinamide, levofloxacin, steptomycin

  • DrugMoxifloxacin and Kanamycin added

    Also known as: Cycloserine, P-aminosalicylic acid, Prothionamide, Pyrazinamide, moxifloxacin, kanamycin

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Park SI, Oh J, Jang K, Yoon J, Moon SJ, Park JS, Lee JH, Song J, Jang IJ, Yu KS, Chung JY. Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers. Antimicrob Agents Chemother. 2015 Aug;59(8):4429-35. doi: 10.1128/AAC.00354-15. Epub 2015 May 18. PubMed 25987620 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02128308
Lead sponsor
Seoul National University Hospital
Responsible party
Jae Yong Chung (Assistant Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
May 1, 2014
Start date
Nov 2013
Primary completion
Dec 2013
Completion
Jan 2014
Last update
May 1, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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