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

April 29, 2014 updated by: Jae Yong Chung, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
  • Pyrazinamide
  • P-aminosalicylic acid
  • Prothionamide
  • 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
  • Pyrazinamide
  • P-aminosalicylic acid
  • Prothionamide
  • moxifloxacin
  • kanamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC (area under the plasma concentration-time curve)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBPK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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