Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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.