[Translation] A single-center, randomized, open-label, two-preparation, two-sequence, four-cycle, fully replicated, cross-bioequivalent study of Rilugolix Tablets (Specification: 120mg) administered to Chinese healthy subjects under fasting and postprandial conditions sexual experiment
"主要研究目的:
考察在空腹和餐后条件下,瑞卢戈利片的受试制剂T(江西山香药业有限公司生产,规格:120mg)及参比制剂R(Myovant Sciences GmbH持证,商品名:ORGOVYX®,规格:120mg)在健康受试者单次服药后的药动学特征,评价受试制剂与参比制剂是否具有生物等效性。
次要研究目的:
观察受试制剂和参比制剂在健康受试者体内的安全性。"
[Translation] "Main research purpose:
The test preparation T (manufactured by Jiangxi Shanxiang Pharmaceutical Co., Ltd., specification: 120 mg) and the reference preparation R (certified by Myovant Sciences GmbH, trade name: ORGOVYX®) were examined under fasting and postprandial conditions. Specification: 120mg) pharmacokinetic characteristics after a single dose in healthy subjects to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary research purpose:
Observe the safety of the test preparation and reference preparation in healthy subjects. "