/ Not yet recruitingNot Applicable 盐酸曲唑酮片(50 mg)在空腹状态下健康人体生物等效性研究
[Translation] Bioequivalence study of trazodone hydrochloride tablets (50 mg) in healthy volunteers in the fasting state
本研究以美时化学制药股份有限公司南投厂生产的盐酸曲唑酮片(规格:50 mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家オルガノン株式会社生产的盐酸曲唑酮片(规格:50 mg,商品名:RESLIN®)为参比制剂,评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。
[Translation] In this study, trazodone hydrochloride tablets (specification: 50 mg) produced by the Nantou Plant of Meishi Chemical Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, trazodone hydrochloride tablets (specification: 50 mg, trade name: RESLIN®) produced by the original manufacturer Olganon Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions.
/ Not yet recruitingNot Applicable 盐酸曲唑酮片(50 mg)在餐后状态下健康人体生物等效性研究
[Translation] Bioequivalence study of trazodone hydrochloride tablets (50 mg) in healthy volunteers in the fed state
本研究以美时化学制药股份有限公司南投厂生产的盐酸曲唑酮片(规格:50 mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家オルガノン株式会社生产的盐酸曲唑酮片(规格:50 mg,商品名:RESLIN®)为参比制剂,评估受试制剂和参比制剂在餐后条件下给药后的生物等效性。
[Translation] In this study, trazodone hydrochloride tablets (specification: 50 mg) produced by the Nantou Plant of Meishi Chemical Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, trazodone hydrochloride tablets (specification: 50 mg, trade name: RESLIN®) produced by the original manufacturer Olganon Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fed conditions.
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