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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Levofloxacin and Streptomycin added; Drug: Moxifloxacin and Kanamycin added

• Registration Number: NCT02128308
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-29
• Last Update Submitted: 2014-04-29
• Study First Posted: 2014-05-01
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin and Streptomycin added	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
Moxifloxacin and Kanamycin added	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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of