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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Aminosalicylic Acid; Antitubercular Agents; Cycloserine; Fluoroquinolones; Kanamycin; Levofloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin; Prothionamide; Pyrazinamide; Streptomycin

Criteria

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.