[Translation] A single-center, randomized, open-label, two-dose, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of trimebutine maleate tablets in Chinese healthy volunteers after fasting and postprandial oral administration
1.研究空腹单次口服马来酸曲美布汀片受试制剂(100mg,持证商:信合援生制药股份有限公司)与马来酸曲美布汀片参比制剂(100mg,持证商:田边三菱制药株式会社)后曲美布汀在中国健康受试者体内的药代动力学行为,评价空腹口服两种制剂的人体生物等效性。
2.研究餐后单次口服马来酸曲美布汀片受试制剂(100mg,持证商:信合援生制药股份有限公司)与马来酸曲美布汀片参比制剂(100mg,持证商:田边三菱制药株式会社)后曲美布汀在中国健康受试者体内的药代动力学行为,评价餐后口服两种制剂的人体生物等效性。
次要目的:评价中国健康受试者空腹和餐后单次口服马来酸曲美布汀片受试制剂和参比制剂后的安全性。
[Translation] 1. To study the pharmacokinetic behavior of trimebutine maleate tablets (100 mg, licensee: Xinhe Yuansheng Pharmaceutical Co., Ltd.) and the reference formulation of trimebutine maleate tablets (100 mg, licensee: Mitsubishi Tanabe Pharma Co., Ltd.) after a single oral administration on an empty stomach in healthy Chinese subjects, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach.
2. To study the pharmacokinetic behavior of trimebutine maleate tablets (100 mg, licensee: Xinhe Yuansheng Pharmaceutical Co., Ltd.) and the reference formulation of trimebutine maleate tablets (100 mg, licensee: Mitsubishi Tanabe Pharma Co., Ltd.) after a single oral administration on an empty stomach in healthy Chinese subjects, and to evaluate the bioequivalence of the two formulations after oral administration on a empty stomach.
Secondary objective: To evaluate the safety of the test and reference formulations of trimebutine maleate tablets in healthy Chinese subjects after a single oral administration on an empty stomach and after a meal.