Hainan Merlot Kang Pharmaceutical Co., Ltd.

The budesonide-formoterol inhalation powder provided by Hainan Meiluokang Pharmaceutical Co., Ltd. (trade name: Gibiter Easyhaler®, specification: 60 inhalations per tube, each containing 320 μg budesonide and 9.0 μg formoterol fumarate, licensed by Orion Pharma) was used as the test preparation, and the budesonide-formoterol inhalation powder licensed by AstraZeneca AB (trade name: Symbicort Turbuhaler®, specification: 60 inhalations per tube, each containing 320 μg budesonide and 9.0 μg formoterol fumarate) was used as the reference preparation to evaluate the bioequivalence of the two preparations in the fasting state, and to evaluate the safety of the two drugs.

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the bioequivalence of the ambroxol hydrochloride oral spray solution (trade name: AMBROSPRAY ® 5%, specification: 13 mL: 650 mg (each spray contains 10 mg ambroxol hydrochloride)) provided by Hainan Meilukang Pharmaceutical Co., Ltd. and the ambroxol hydrochloride oral solution (trade name: Mucosolvan®, specification: 15 mg/5 mL) certified by OPELLA HEALTHCARE AUSTRIA GMBH in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of the ambroxol hydrochloride oral spray solution provided by Hainan Meilukang Pharmaceutical Co., Ltd.

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to evaluate the oral bioequivalence of vardenafil hydrochloride orodisintegrating tablets (10 mg) provided by Hainan Meilukang Pharmaceutical Co., Ltd. and vardenafil hydrochloride orodisintegrating tablets (10 mg) certified by Alembic Pharmaceuticals Inc. in healthy male population after fasting and postprandial administration, to provide evidence for the consistency of clinical efficacy of vardenafil hydrochloride orodisintegrating tablets provided by Hainan Meilukang Pharmaceutical Co., Ltd. and vardenafil hydrochloride orodisintegrating tablets certified by Alembic Pharmaceuticals Inc., and to evaluate the safety and tolerability of vardenafil hydrochloride orodisintegrating tablets (10 mg) provided by Hainan Meilukang Pharmaceutical Co., Ltd.