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Completed

NCT Number: NCT02128308

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

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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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levofloxacin and Streptomycin added

Drug

Other names: Cycloserine, P-aminosalicylic acid, Prothionamide, Pyrazinamide, levofloxacin, steptomycin

Moxifloxacin and Kanamycin added

Drug

Other names: Cycloserine, P-aminosalicylic acid, Prothionamide, Pyrazinamide, moxifloxacin, kanamycin

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 1, 2014
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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