Clinical Trial Phase I of Antituberculosis Dry Powder Aerosols
18 Years
45 Years
Both
Healthy
Trial Information
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).
Inclusion Criteria:
- Aged 18-45 years
- Body mass index 18-27 kg/m2
- Healthy
- In the case of reproductive age woman, effective contraceptive will be used for at
least 4 weeks prior to a screening examination until the end of study.
- Non-lactating women
- Patients who are willing to participate in the trial and will first sign the informed
consent form.
Exclusion Criteria:
- Allergic to any antituberculosis drugs or other components
- High blood pressure (diastolic pressure > 90 mmHg)
- Liver enzymes (AST and ALT) > 2 times of upper normal value
- Pregnancy or lactation
- No underlying diseases such as asthma, COPD, chronic kidney disease, diabetes
mellitus, liver disease, immunocompromised deficiency, etc.
- HBsAg positive
- Abnormality in chest X-ray or routine laboratory tests
- Smokers > 10 cigarette/day or smokers < 10 cigarettes/day who could not quit at least
7 days before study and throughout study (including the washout between periods)
- Regular alcohol consumption (more than 1 time/week) or alcohol consumption within 7
days prior to the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Outcome Measure:
Cytokine levels (Tumor Necrosis Factor-α and Interleukin-1β)
Outcome Time Frame:
Two months
Safety Issue:
Yes
Authority:
Thailand: Ministry of Public Health
Study ID:
RES.no. 18/2554
NCT ID:
NCT01785927
Start Date:
February 2013
Completion Date:
April 2013
Related Keywords:
- Healthy
- Antituberculosis
- Dry powder aerosols
- Inhalation
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