Yabao Medicine Sichuan Pharmaceutical Co. Ltd.

The pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behavior of the test preparation Dienogest Tablets (manufacturer: Sichuan Yabao Pharmaceutical Co., Ltd.) and the reference preparation Dienogest Tablets (licensed manufacturer: Jenapharm GmbH & Co. KG, trade name: Visanning®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. The safety of the test preparation Dienogest Tablets and the reference preparation Dienogest Tablets in healthy subjects was observed.

The pharmacokinetic characteristics of the test preparation, montelukast sodium granules T (specification: 0.5g:4mg, calculated as montelukast, produced by Yabao Pharmaceutical Sichuan Pharmaceutical Co., Ltd.) and the reference preparation, montelukast sodium granules R (trade name: Singulair®, specification: 0.5g:4mg, calculated as montelukast, produced by Merck Sharp & Dohme Corp) were observed in healthy adult Chinese subjects after a single oral administration in the fasting and fed state, and the bioequivalence and intra-individual variability between T and R were preliminarily evaluated after oral administration of the two preparations in the fasting and fed state, respectively. The safety of the test preparation and the reference preparation 0.5g:4mg in healthy adult Chinese subjects after a single oral administration in the fasting and fed state was observed.

Main study objective: Through bioequivalence study, the in vivo pharmacokinetic characteristics of the test preparation ibuprofen suspension (specification: 100 mL: 2 g, developed by Yabao Pharmaceutical Sichuan Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen suspension (trade name: Meilin®, specification: 100 mL: 2 g, licensed by Shanghai Johnson & Johnson Pharmaceutical Co., Ltd.) were investigated in healthy Chinese participants after a single oral administration under meal conditions, and the bioequivalence of the two preparations was evaluated. Secondary study objective: To evaluate the safety of the test preparation and reference preparation of ibuprofen suspension 100 mL: 2 g after a single oral administration in healthy Chinese participants.