[Translation] Single-centre, randomized, open-label, two-dose, single-dose, three-sequence, three-period, partial-repeat crossover design bioequivalence of trimebutine maleate tablets in Chinese healthy subjects sex test
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. Study the test preparation of trimebutine maleate tablets (100mg, certificate holder: Xinhe Yuansheng Pharmaceutical Co., Ltd.) and the reference preparation of trimebutine maleate tablets (100mg, holding Vendor: Tanabe Mitsubishi Pharmaceutical Co., Ltd.) After the pharmacokinetic behavior of trimebutine in Chinese healthy subjects, evaluate the human bioequivalence of two preparations taken orally on an empty stomach.
2. To study the test preparation of trimebutine maleate tablets (100mg, certificate holder: Xinhe Yuansheng Pharmaceutical Co., Ltd.) and the reference preparation of trimebutine maleate tablets (100mg, Licensee: Tanabe Mitsubishi Pharmaceutical Co., Ltd.) The pharmacokinetic behavior of trimebutine in Chinese healthy subjects, and the evaluation of human bioequivalence of two preparations after meals.
Secondary objective: To evaluate the safety of trimebutine maleate tablets of the test preparation and the reference preparation after oral administration of trimebutine maleate tablets in an empty stomach and after meals in Chinese healthy subjects.