Bioequivalence test of ibuprofen sustained-release capsules in healthy subjects: a single center, randomized, open, single dose, two cycles, cross fasting and postprandial study

Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2020
INTERVENTION: Fasting A group:TR;Fasting B group:RT;Fed A group:TR;Fed B group:RT; CONDITION: Relieve pain from mild to moderate such as arthralgia, muscle , neuralgia, headache, migraine, toothache, dysmenorrhea,and fever caused by common cold or influenza. fever caused by common cold PRIMARY OUTCOME: Cmax;AUC0‐t;AUC0‐8; INCLUSION CRITERIA: 1) The subjects must give informed consent to the study before the trial, and sign the written informed consent voluntarily; 2) Gender: Chinese healthy male or female subjects, both male and female; 3) Aged 18‐65 (including 18, excluding 65) years; 4) Weight: male >= 50.0kg, female >= 45.0kg; BMI [BMI = body weight (kg) / height 2 (m2)] in the range of 19.0‐26.0kg/m2 (including boundary value); 5) The subjects can communicate with the researchers well ,understand and comply with the requirements of this study;
Epistemonikos ID: 2fb3f101d88104c458af1b5f45ad7d4b1dfe82e7
First added on: Aug 24, 2024