Single-center randomized open two-preparation, two-sequence and two-cycle crossover bioequivalence trial of claborol ointment (specification: 30g/2%) given topically in Chinese healthy volunteers on an empty stomach

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Group TR:In the first cycle, the subject applied the test preparation on an empty stomach;The second cycle of cross administration after 4 days;Group RT:In the first cycle, the subject applied the reference preparation on an empty stomach;The second cycle of cross administration after 4 days; CONDITION: Atopic dermatitis PRIMARY OUTCOME: Plasma Concentration; INCLUSION CRITERIA: 1) Sign the informed consent before the test and fully understand the test contents and possible adverse reactions; 2) Be able to complete the research according to the requirements of the test scheme; 3) Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last study drug administration. See Appendi X5 for specific contraceptive measures; 4) Male and female subjects aged 18 50 years (including 18 years old and 50 years old); 5) The weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg. The body mass inde X[BMI= weight (kg)/height 2 (m2)] is in the range of 19.0 28.0 kg/m2 (including critical value); 6) Physical examination of normal or abnormal vital signs has no clinical significance
Epistemonikos ID: 25e2c1ad2ff617e9518d5037b035d41914a5b48d
First added on: Feb 20, 2024