Regulations of Bioavailability and Bioequivalence Studies Article 14

A randomized two or more way crossover designs or Latin Square Designs is recommended to reduce the intersubject differences for bioavailability and bioequivalence studies. Under certain circumstances, parallel designs can be adopted and the number of subjects in each arm should be properly determined.Healthy subjects should abstain from any medicines for at least two weeks before the study.Subjects should fast for at least 10 hours prior to administration of the drug except for a food-effect bioavailability or bioequivalence study. If Food Effect study is conducted, subjects should fast at least 10 hours before food intake.A standard meal should be provided no less than 4 hours after drug administration.In addition to the preceding Subparagraph 1, for immediate-release products, a single dose-fasting study should be conducted. In the case of the administration with food is recommended according to package insert of the reference/innovator products, a single dose-fed study should be conducted instead, unless otherwise justified.In addition to paragraph 1 in this article, for modified-release products, both single dose-fasting and single dose-fed studies should be conducted, unless otherwise justified.