Taiwan Biotech Co. Ltd.

To evaluate the efficacy and safety of compound ipratropium bromide solution for inhalation developed and produced by Xindong Biotech Co., Ltd. in patients with acute exacerbation of chronic obstructive pulmonary disease, using compound ipratropium bromide solution for inhalation (produced by Boehringer Ingelheim) as a control.

To investigate the pharmacokinetic behavior of montelukast sodium tablets (10 mg/tablet; Xindong Biotech Co., Ltd.) and reference preparation (Singulair®; 10 mg/tablet, imported from Merck Sharp & Dohme Ltd. (U.K.) in Chinese healthy volunteers after single oral administration on an empty stomach and after a meal, and to evaluate the bioequivalence of the two preparations after oral administration on an empty stomach and after a meal. Secondary objective: To evaluate the safety of the test and reference preparations of montelukast sodium tablets in Chinese healthy volunteers after a single oral administration.

To study the absorption rate and extent of montelukast after oral administration of a single dose of the test drug and the reference drug to healthy Chinese male subjects, and to evaluate whether the test preparation and the reference preparation are bioequivalent.