[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation Fertin Pharma A/S nicotine chewing gum 2 mg (mint flavor) and the reference preparation McNeil Denmark ApS nicotine chewing gum 2 mg (trade name: Nicorette®, cool mint flavor) in healthy adult smoking subjects under fasting conditions
主要试验目的:比较空腹状态下单次给予受试制剂尼古丁咀嚼胶(薄荷味,规格:2 mg;Fertin Pharma A/S生产)与参比制剂尼古丁咀嚼胶(Nicorette®,清凉薄荷味,规格:2 mg;McNeil AB, Helsingborg, Sweden生产)在健康吸烟受试者体内的药代动力学,评价空腹状态咀嚼两种制剂的生物等效性。
次要试验目的:研究受试制剂尼古丁咀嚼胶(薄荷味,规格:2 mg;Fertin Pharma A/S生产)和参比制剂尼古丁咀嚼胶(Nicorette®,清凉薄荷味,规格:2 mg;McNeil AB, Helsingborg, Sweden生产)在健康吸烟受试者中的安全性。
[Translation] Primary study objective: To compare the pharmacokinetics of a single dose of the test nicotine chewing gum (menthol flavor, strength: 2 mg; produced by Fertin Pharma A/S) and the reference nicotine chewing gum (Nicorette®, cool mint flavor, strength: 2 mg; produced by McNeil AB, Helsingborg, Sweden) in healthy smokers in the fasting state and to evaluate the bioequivalence of the two chewing gums in the fasting state.
Secondary study objective: To investigate the safety of the test nicotine chewing gum (menthol flavor, strength: 2 mg; produced by Fertin Pharma A/S) and the reference nicotine chewing gum (Nicorette®, cool mint flavor, strength: 2 mg; produced by McNeil AB, Helsingborg, Sweden) in healthy smokers.