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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Levofloxacin and Streptomycin added

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Moxifloxacin and Kanamycin added

Intervention Type DRUG

Interventions

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Levofloxacin and Streptomycin added

Intervention Type DRUG

Moxifloxacin and Kanamycin added

Intervention Type DRUG

Other Intervention Names

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Cycloserine P-aminosalicylic acid Prothionamide Pyrazinamide levofloxacin steptomycin Cycloserine P-aminosalicylic acid Prothionamide Pyrazinamide moxifloxacin kanamycin

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes