A randomized, open, two sequence, two cycle, double crossover design bioequivalence trial of Pyrazinamide tablets for single oral administration on an empty stomach and after meals in healthy Chinese subjects

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Fasting R‐T group:Subjects take one tablet of reference preparation in the first cycle and one tablet of test preparation in the second cycle on an empty stomach;Fasting T‐R group:Subjects take one tablet of test preparation in the first cycle and one tablet of reference preparation in the second cycle on an empty stomach;Postprandial R‐T group:After taking a high‐fat meal, the subjects took one tablet of reference preparation in the first cycle and one tablet of test preparation in the second cycle;Postprandial T‐R group:After taking a high‐fat meal, the subjects took one tablet of test preparation in the first cycle and one tablet of reference preparation in the second cycle; CONDITION: Initial treatment of active tuberculosis in adults and children PRIMARY OUTCOME: Cmax;AUC0‐t;AUC0‐8; SECONDARY OUTCOME: Tmax;t1/2;AUC_%Extrap;?z; INCLUSION CRITERIA: 1. Healthy male or female subjects over the age of 18 (inclusive); 2. The body mass inde Xis in the range of 19.0 26.0 kg/m2 (including the critical value), and the weight of men is not less than 50 kg, and the weight of women is not less than 45 kg; 3. Screened within two weeks before the test, after vital sign evaluation, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, infectious disease screening, pregnancy examination (women), 12‐lead electrocardiogram and chest x‐ray examination and other test results judged by the study doctor to be no abnormality or abnormal and clinically meaningless; 4. Those who have no abnormalities after drug abuse screening and alcohol breath test; 5. The subject did not have a family plan within 6 months after the end of the trial and voluntarily adopted effective contraceptive measures prescribed by the program, and the contraceptive measures are detailed in Appendi X4; 6.
Epistemonikos ID: b16aac0fdb3383eded9d868b2d7809b966a24c0a
First added on: Aug 26, 2024