[Translation] Evaluation of the test formulation Fertin Pharma A/S nicotine chewing gum 4 mg (mint flavor) versus the reference formulation McNeil Denmark ApS nicotine chewing gum 4 mg (trade name: Nicorette®, cool mint flavor) in healthy adult smoking subjects on an empty stomach A single-center, open-label, randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence study under
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:4 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:4 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:4 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:4 mg;McNeil AB, Helsingborg, Sweden生产)在健康吸烟受试者中的安全性。
[Translation] Main test purpose: To compare the test preparation nicotine chewing gum (mint flavor, specification: 4 mg; manufactured by Fertin Pharma A/S) and the reference preparation nicotine chewing gum (Nicorette®, cool mint flavor, specification: 4 mg; produced by McNeil AB, Helsingborg, Sweden) pharmacokinetics in healthy smoking subjects, evaluating the bioequivalence of the two formulations chewed in the fasting state.
Secondary trial purpose: To study the test formulation nicotine chewing gum (mint flavor, strength: 4 mg; manufactured by Fertin Pharma A/S) and the reference formulation nicotine chewing gum (Nicorette®, cool mint flavor, strength: 4 mg; McNeil AB , Helsingborg, Sweden) safety in healthy smoking subjects.