[Translation] A randomized, open-label, two-sequence, two-cycle, double-crossover human bioequivalence trial of fluoxetine hydrochloride capsules
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 purpose:
1. To study the test preparation (20mg/capsule, Changzhou Watson Pharmaceutical Co., Ltd.) and the reference preparation (20mg/capsule, license holder: LILLY FRANCE) of fluoxetine hydrochloride capsules on an empty stomach in China Pharmacokinetic behavior in healthy subjects, evaluating the bioequivalence of two formulations administered orally on an empty stomach.
2. Study the test preparation of fluoxetine hydrochloride capsule (20mg/capsule, Changzhou Watson Pharmaceutical Co., Ltd.) and the reference preparation of fluoxetine hydrochloride capsule (20mg/capsule, license holder: LILLY FRANCE) after meal Pharmacokinetic behavior in healthy Chinese subjects, evaluating the bioequivalence of two formulations administered orally after a meal.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of fluoxetine hydrochloride capsules after a single oral dose of fluoxetine hydrochloride capsules in Chinese healthy subjects.