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/ Not yet recruitingNot Applicable 盐酸西替利嗪干糖浆在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of cetirizine hydrochloride dry syrup in healthy volunteers under fasting/fed conditions
主要目的:本研究以海南元盈医药科技有限公司持证的盐酸西替利嗪干糖浆为受试制剂,ユーシービージャパン株式会社生产的盐酸西替利嗪干糖浆(商品名:Zyrtec® Dry Syrup)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: This study used the cetirizine hydrochloride dry syrup certified by Hainan Yuanying Pharmaceutical Technology Co., Ltd. as the test preparation and the cetirizine hydrochloride dry syrup (trade name: Zyrtec® Dry Syrup) produced by Yushibizapan Co., Ltd. as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ Not yet recruitingNot Applicable 左乙拉西坦微片在健康人体空腹/餐后状态下的随机、开放、双周期、双交叉设计生物等效性试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of levetiracetam microtablets in healthy volunteers under fasting/fed conditions
主要目的:本研究以海南元盈医药科技有限公司持证的左乙拉西坦微片为受试制剂,以Desitin Arzneimittel GmbH持证的左乙拉西坦微片(Desitin)为参比制剂,进行空腹/餐后状态下的人体生物等效性试验,评价受试制剂和参比制剂在健康参与者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Main purpose: This study used the levetiracetam microtablets certified by Hainan Yuanying Pharmaceutical Technology Co., Ltd. as the test preparation and the levetiracetam microtablets (Desitin) certified by Desitin Arzneimittel GmbH as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy participants.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy participants.
/ Active, not recruitingNot Applicable 乙酰半胱氨酸片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of acetylcysteine tablets in healthy volunteers under fasting and fed conditions
主要目的:本研究以海南元盈医药科技有限公司持证的乙酰半胱氨酸片为受试制剂,Zambon Nederland B.V.持证的乙酰半胱氨酸片(商品名:Fluimucil)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
[Translation] Main objective: This study used acetylcysteine tablets certified by Hainan Yuanying Pharmaceutical Technology Co., Ltd. as the test preparation and acetylcysteine tablets (trade name: Fluimucil) certified by Zambon Nederland B.V. as the reference preparation to conduct a human bioequivalence study under fasting/fed conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
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