tuberculosis
Conditions
Interventions
1:Phase I: oral administration of Four FDC tablets (150mg rifampicin, 75mg isoniazid, 275mg ethambutol and 400mg pyrazinamide per tablet). Phase II: oral administration of reference formulations: rifa
2:Phase I: oral administration of reference formulations: rifampicin (4×150mg), isoniazid tablets (3×100mg), ethambutol (4×250mg) and pyrazinamide (6×250mg)
Phase II: oral administration of Four FDC tablets (150mg rifampicin, 75mg isoniazid, 275mg ethambutol and 400mg pyrazinamide per tablet).
Sponsors
Beijing Tuberculosis and Thoracic Tumor Research Institute
Eligibility
Sex/Gender
Male
Age
26 Years to 49 Years
Inclusion criteria
Inclusion criteria: Healthy male volunteers were screened by performing medical history, physical examination, blood pressure, hemogram, liver function tests, HBV, chest X-ray, electrocardiogram and routine urine analysis. Eligible healthy subjects had to be aged between 18 and 55 years and weighing more than 50 kg with no history of tobacco or alcohol abuse, heart liver kidney or gastro-intestinal disorders. Willingness to follow the protocol requirement as evidenced by written, informed consent.
Exclusion criteria
Exclusion criteria: Subjects were excluded if they had a history of allergies to related drugs; a history of metabolic diseases and a medication history before initiating study 2 weeks. 1. With any disease or condition which might compromise the haemopoietic, renal, hepatic, pulmonary, central nervous, cardiovascular, immunological, gastrointestinal or any other systems; 2. Allergic reaction to any drug, postural hypotension, blood pressure (systolic140 mmHg; diastolic>90 mmHg) heart rate100 bpm; 10. Positive serum hepatitis B surface antigen or hepatitis C antibody; 11. Consumption of alcohol during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-24);Cmax; | — |
Countries
China
Contacts
Public ContactYu Lu
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed