Shandong Kongfu Pharmaceutical Factory

The primary study objective is to evaluate the absorption rate and extent of ambrisentan tablets and Vanrexel® in healthy male subjects under fasting conditions, and to evaluate whether the two preparations are bioequivalent. The secondary study objective is to evaluate the safety of the test preparation ambrisentan tablets and the reference preparation Vanrexel® in healthy male subjects in China.

The primary study objective is to evaluate the absorption rate and extent of ambrisentan tablets and Vanrexol® in healthy male subjects after meals, and to evaluate whether the two preparations are bioequivalent. The secondary study objective is to evaluate the safety of the test preparation ambrisentan tablets and the reference preparation Vanrexol® in healthy male subjects in China.

The main purpose of the study was to use Erlotinib Hydrochloride Tablets produced by Kongfu Pharmaceutical as the test preparation and Erlotinib Hydrochloride Tablets (trade name: Tarceva®) produced by Roche S.P.A. as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of Erlotinib Hydrochloride Tablets in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations. The secondary purpose of the study was to evaluate the safety of the test preparation and the reference preparation of Erlotinib Hydrochloride Tablets after a single oral administration on an empty stomach in healthy Chinese subjects.