[Translation] Bioequivalence study of melogabalin besylate tablets in healthy participants under fasting and postprandial conditions, using a single-dose, randomized, open-label, two-period, two-sequence, self-crossover design.
主要目的:本研究以海南海灵化学制药有限公司持证的苯磺酸美洛加巴林片为受试制剂,第一三共株式会社持证的苯磺酸美洛加巴林片(Tarlige)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Primary Objective: This study used merogalaline besylate tablets (licensed by Hainan Hailing Chemical Pharmaceutical Co., Ltd.) as the test formulation and merogalaline besylate tablets (Tarlige) (licensed by Daiichi Sankyo Co., Ltd.) as the reference formulation to conduct a human bioequivalence study under fasting and postprandial conditions to evaluate the bioequivalence of the test and reference formulations in healthy subjects.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.