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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Levofloxacin and Streptomycin added
* Drug: Moxifloxacin and Kanamycin added


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levofloxacin and Streptomycin added<br>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<br> <br> * Other names: steptomycin;|
| Experimental: Moxifloxacin and Kanamycin added<br>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<br> <br> * Other names: kanamycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the plasma concentration-time curve) | AUC (Area under the plasma concentration versus time curve), Cmax(maximum plasma concentration) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antituberculosis agents, Pharmacokinetics