[Translation] A randomized, open, two-sequence, two-period, double-crossover bioequivalence study of fluoxetine hydrochloride capsules in humans
主要目的:
1.研究空腹单次口服盐酸氟西汀胶囊受试制剂(20mg/粒,常州华生制药有限公司)与盐酸氟西汀胶囊参比制剂(20mg/粒,持证商:LILLY FRANCE)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生物等效性。
2.研究餐后单次口服盐酸氟西汀胶囊受试制剂(20mg/粒,常州华生制药有限公司)与盐酸氟西汀胶囊参比制剂(20mg/粒,持证商:LILLY FRANCE)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生物等效性。
次要目的:评价中国健康受试者单次口服盐酸氟西汀胶囊受试制剂和参比制剂后的安全性。
[Translation] Main objectives:
1. To study the pharmacokinetic behavior of the test formulation of fluoxetine hydrochloride capsules (20 mg/pill, Changzhou Watson Pharmaceuticals Co., Ltd.) and the reference formulation of fluoxetine hydrochloride capsules (20 mg/pill, licensee: LILLY FRANCE) in healthy Chinese subjects after a single oral administration on an empty stomach, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach.
2. To study the pharmacokinetic behavior of the test formulation of fluoxetine hydrochloride capsules (20 mg/pill, Changzhou Watson Pharmaceuticals Co., Ltd.) and the reference formulation of fluoxetine hydrochloride capsules (20 mg/pill, licensee: LILLY FRANCE) in healthy Chinese subjects after a single oral administration on a empty stomach, and to evaluate the bioequivalence of the two formulations after oral administration on a empty stomach.
Secondary objectives: To evaluate the safety of the test formulation and the reference formulation of fluoxetine hydrochloride capsules in healthy Chinese subjects after a single oral administration on an empty stomach.