Hunan Yinze Huahao Biotechnology Co., Ltd.

Main research purpose Using amlodipine besylate tablets (trade name: Norvasc®, 10mg) certified by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation and levamlodipine besylate tablets (5mg) provided by Hunan Yinze Huahao Biotechnology Co., Ltd. as the test preparation, the human bioequivalence of the two preparations was evaluated through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study in the fasting/postprandial state. Secondary research purpose Evaluate the safety of the test preparation and reference preparation after a single fasting/postprandial oral administration in the Chinese Health Study participants.

Main study objectives: To study the pharmacokinetics of the test formulation of nifedipine controlled-release tablets (30 mg) (developed by Hunan Yinze Huahao Biotechnology Co., Ltd.) and the reference formulation of nifedipine controlled-release tablets (30 mg) (Adalat®, Bayer Pharma AG / Bayer AG) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two formulations in the fasting and fed state. Secondary study objectives: To evaluate the safety of the test formulation and reference formulation of nifedipine controlled-release tablets (30 mg) in healthy subjects after a single oral administration in the fasting and fed state.

Primary purpose: This study used the calcitriol capsules certified by Hunan Yinze Huahao Biotechnology Co., Ltd. as the test preparation and the calcitriol capsules (Rocaltrol®) certified by Roche Pharma (Schweiz) AG as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.