Randomized, open, two-formulation, two-cycle, crossover, fasting and postprandial administration bioequivalence trial in healthy humans of Cargolizine tablets

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Fasting R‐T group:Subjects take one tablet of R medication in the first cycle and one tablet of T medication in the second cycle on an empty stomach;Fasting T‐R group:Subjects take one tablet of T medication in the first cycle and one tablet of R medication in the second cycle on an empty stomach;Postprandial T‐R group:After taking a high‐fat meal, the subjects took one tablet of T‐medication in the first cycle and one tablet of R‐medication in the second cycle;Postprandial R‐T group:After taking a high‐fat meal, the subjects took one tablet of R‐medication in the first cycle and one tablet of T‐medication in the second cycle; CONDITION: Diabetes PRIMARY OUTCOME: plasma concentration;Cmax;AUC0‐8; INCLUSION CRITERIA: Meet all the inclusion criteria to be selected. 1) Those who voluntarily signed the informed consent form before the trial, fully understood the content, procedure and possible adverse effects of the trial, and voluntarily participated in the trial; 2) Healthy subjects aged 18 to 65 years (including the threshold); 3) Both sexes, male weight = 50.0 kg, female weight = 45.0 kg, body mass inde X(BMI) in the range of 19.0 26.0 kg/m2 (including the critical value) [body mass inde X(BMI) = weight (kg)/height2 (m2)]; 4) Physical examination, vital signs examination, laboratory tests (routine blood, blood biochemistry, coagulation, routine urine, blood pregnancy (only for female subjects of childbearing age), transfusion IV), and electrocardiogram results that are judged by the investigator to be normal or abnormal without clinical significance; 5) Those who are able to communicate well with the investigator and understand and comply with the requirements of
Epistemonikos ID: 85cacb6e9de39e1204fa437b49e25e89fd0df6de
First added on: Feb 20, 2024