Hubei Hengan Fulin Pharmaceutical Co., Ltd.

Primary objective: To compare the differences in absorption degree and speed of crisaborole ointment (specification: 2%, 30g/tube, test preparation) provided by Hubei Hengan Fulin Pharmaceutical Co., Ltd. and crisaborole ointment (trade name: Sutanming®, specification: 2%, 30g/tube, reference preparation) produced by Anacor Pharmaceuticals, Inc. and Pharmacia and Upjohn Company LLC under the condition of single administration on an empty stomach in healthy subjects. The main pharmacokinetic parameters were used to evaluate whether the two were bioequivalent, and to provide a basis for the registration application of the test preparation. Secondary objective: To evaluate the safety of crisaborole ointment by observing the safety indicators of healthy subjects after a single application of the test preparation and the reference preparation.

The purpose of this study is to use terbinafine hydrochloride tablets produced by Hubei Hengan Fulin Pharmaceutical Co., Ltd. as the test preparation and terbinafine hydrochloride tablets (trade name: Lamisil) produced by Sun Pharmaceutical Industries Limited as the reference preparation, to evaluate whether the two preparations are bioequivalent in the fasting and fed states in accordance with NMPA regulations and other requirements; to observe the safety of the test preparation terbinafine hydrochloride tablets and the reference preparation Lamisil in healthy subjects in the fasting and fed states.

This trial is a superiority trial, which observes and evaluates the effectiveness and safety of Shixin lozenges in the treatment of recurrent oral ulcers (stomach fire inflammation syndrome) by comparing with placebo.