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

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ClinicalTrials.gov Identifier: NCT02128308
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Bundang 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Levofloxacin and Streptomycin added Drug: Moxifloxacin and Kanamycin added Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014


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




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128308


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Yong Chung, Assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02128308     History of Changes
Other Study ID Numbers: TBPK
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Jae Yong Chung, Seoul National University Bundang Hospital:
Antituberculosis agents
Pharmacokinetics

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Moxifloxacin
Levofloxacin
Ofloxacin
Cycloserine
Pyrazinamide
Aminosalicylic Acid
Streptomycin
Prothionamide
Kanamycin
Norgestimate, ethinyl estradiol drug combination
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Infective Agents, Urinary