Henan Zhongshuai Pharmaceutical Co., Ltd.

Primary objective: To evaluate the effectiveness of acetazolamide extended-release capsules in preventing acute mountain sickness compared with placebo. Secondary objective: To evaluate the safety of acetazolamide extended-release capsules in preventing acute mountain sickness.

The main purpose of the study is to use the acetazolamide tablets (specification: 250 mg) licensed by Taro Pharmaceuticals U.S.A., Inc. as the reference preparation and the acetazolamide tablets (specification: 0.25 g) developed by Henan Zhongshuai Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, single-dose, randomized, open, two-period, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation dexmethylphenidate hydrochloride sustained-release capsules (manufacturer: Henan Zhongshuai Pharmaceutical Co., Ltd.) and the reference preparation dexmethylphenidate hydrochloride sustained-release capsules (licensed by Novartis Pharmaceuticals Corporation, trade name: Focalin XR) in healthy subjects after oral administration under fasting/postprandial/mixed conditions was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation dexmethylphenidate hydrochloride sustained-release capsules and the reference preparation dexmethylphenidate hydrochloride sustained-release capsules in healthy subjects.