Ibuprofen/Phenylephrine Hydrochloride

Main purpose: A single-center, randomized, open, single-dose, three-cycle partial repeated crossover fasting administration and four-cycle complete repeated crossover meal administration design were used to compare the differences in absorption degree and speed of ibuprofen tablets (specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) provided by Shandong Xinhua Pharmaceutical Co., Ltd. and the original ibuprofen tablets (trade name: Advil Congestion Relief®, specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) certified by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC in healthy people. Secondary objective: To evaluate the safety and tolerability of ibuprofen tablets (specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) provided by Shandong Xinhua Pharmaceutical Co., Ltd. and original ibuprofen tablets (trade name: Advil Congestion Relief®, specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) licensed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC under fasting and postprandial conditions.

Main purpose: Using Advil® Congestion Relief (200mg: 10mg) produced by Pfizer as the reference preparation and Ibuprofen Phenylephrine Tablets (200mg: 10mg) produced by Kangzhi Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, three-period, partially repeated crossover clinical trial design was conducted to evaluate the bioequivalence of the two preparations under fasting conditions in healthy Chinese subjects. Secondary purpose: Evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.