Clinical Trial Phase I of Antituberculosis Dry Powder Aerosols
Four formulations of antituberculosis drug (rifampicin, isoniazid, pyrazinamide, and
levofloxacin) will be administered to each patient by randomization. Each formulation will
be assigned the code, such as A, B, C, or D, and the treatment sequences will be generated
as ABCD (sequence 1), BCDA (sequence 2), CDAB (sequence 3) and DABC (sequence 4). On the
first day of drug dosing in period I, volunteers will be randomly assigned to a sequence of
treatments as indicated in a pre-printed randomization scheme, which was generated using
block randomization with block sizes of 4 and 6, and the allocation ratio of 1:1. Subjects
will be stratified by sex. Subjects in sequence 1 will receive treatment A during the first
study period and will then cross over to receive treatment B, C, and D at the second, third
and fourth periods, respectively (each after a 7-day washout period).
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Cytokine levels (Tumor Necrosis Factor-α and Interleukin-1β)
Two months
Yes
Thailand: Ministry of Public Health
RES.no. 18/2554
NCT01785927
February 2013
April 2013
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