Tuberculosis Clinical Trial
Official title:
Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia
Verified date | November 2020 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.
Status | Completed |
Enrollment | 23 |
Est. completion date | May 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment. - Subject is 18-55 years of age at the day of the first dosing of study medication. - Subject has a normal ECG - Subjects bodyweight is >35kg - Use of rifampicin and isoniazid Exclusion Criteria: - Pregnant or lactating - History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus. - Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin. - Subject is not able and/or not willing to sign the informed consent form. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Rumah Sakit Hasan Sadikin (RSHS) | Bandung |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Indonesia,
Nijland HM, Ruslami R, Suroto AJ, Burger DM, Alisjahbana B, van Crevel R, Aarnoutse RE. Rifampicin reduces plasma concentrations of moxifloxacin in patients with tuberculosis. Clin Infect Dis. 2007 Oct 15;45(8):1001-7. Epub 2007 Sep 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic (24 hrs) curves will be drawn | |||
Primary | at day 5 in period I and period II. |
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