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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02128308

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Levofloxacin and Streptomycin added Drug: Moxifloxacin and Kanamycin added	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Other Names: Cycloserine P-aminosalicylic acid Prothionamide Pyrazinamide levofloxacin steptomycin
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 Other Names: Cycloserine P-aminosalicylic acid Prothionamide Pyrazinamide moxifloxacin kanamycin

Arm

Intervention/Treatment

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

Other Names:

Cycloserine

P-aminosalicylic acid

Prothionamide

Pyrazinamide

levofloxacin

steptomycin

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

Other Names:

Cycloserine

P-aminosalicylic acid

Prothionamide

Pyrazinamide

moxifloxacin

kanamycin

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

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:

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.