[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of acetaminophen and ibuprofen oral suspension in healthy participants under fasting and fed conditions

研究空腹与餐后状态下单次口服受试制剂（对乙酰氨基酚布洛芬口服混悬液，规格：100ml：对乙酰氨基酚3.2g与布洛芬0.96g，华益药业科技（安徽）有限公司持证）参比制剂（对乙酰氨基酚布洛芬口服混悬液，规格：每毫升含对乙酰氨基酚32mg，布洛芬9.6mg，商品名：Tachifenekid，Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.P.A 持证）在健康参与者体内的药代动力学特征，比较受试制剂与参比制剂的生物等效性，并研究药物在健康参与者体内的安全性。

[Translation]

To study the pharmacokinetic characteristics of a single oral dose of the test preparation (acetaminophen ibuprofen oral suspension, specification: 100ml: 3.2g acetaminophen and 0.96g ibuprofen, licensed by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (acetaminophen ibuprofen oral suspension, specification: 32mg acetaminophen and 9.6mg ibuprofen per ml, trade name: Tachifenekid, licensed by Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.P.A.) in healthy participants under fasting and fed conditions, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drug in healthy participants.

Start Date31 Mar 2025

Sponsor / Collaborator

Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

CTR20250441

/ CompletedNot Applicable

对乙酰氨基酚布洛芬片在健康受试者中餐后条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验

[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of acetaminophen ibuprofen tablets in healthy volunteers after a meal

研究餐后状态下单次口服受试制剂（对乙酰氨基酚布洛芬片，规格：每片含对乙酰氨基酚250mg，布洛芬125mg，华益药业科技（安徽）有限公司持证）与参比制剂（对乙酰氨基酚布洛芬片，规格：每片含对乙酰氨基酚250mg，布洛芬125mg，商品名：ADVIL DUAL ACTION WITH ACETAMINOPHEN，Glaxosmithkline Consumer Healthcare Holdings US LLC持证）在健康受试者体内的药代动力学特征，比较受试制剂与参比制剂的生物等效性，并研究药物在健康受试者体内的安全性。

[Translation]

To study the pharmacokinetic characteristics of the test preparation (acetaminophen ibuprofen tablets, specifications: each tablet contains 250 mg acetaminophen and 125 mg ibuprofen, licensed by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (acetaminophen ibuprofen tablets, specifications: each tablet contains 250 mg acetaminophen and 125 mg ibuprofen, trade name: ADVIL DUAL ACTION WITH ACETAMINOPHEN, licensed by Glaxosmithkline Consumer Healthcare Holdings US LLC) after a single oral administration in healthy subjects in the fed state, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drug in healthy subjects.

Start Date19 Mar 2025

Sponsor / Collaborator

Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

CTR20244960

/ CompletedNot Applicable

氯雷他定片在健康受试者中空腹条件下开放、随机、单次给药、两制剂、两序列、四周期完全重复交叉设计生物等效性试验

[Translation] An open, randomized, single-dose, two-formulation, two-sequence, four-period completely repeated crossover bioequivalence study of loratadine tablets in healthy subjects under fasting conditions

研究空腹状态下单次口服受试制剂（氯雷他定片，规格10mg，华益药业科技（安徽）有限公司持证）与参比制剂（氯雷他定片，规格10mg，商品名：开瑞坦，拜耳医药（上海）有限公司持证）在健康受试者体内的药代动力学特征，比较受试制剂与参比制剂的生物等效性，并研究药物在健康受试者体内的安全性。

[Translation]

To study the pharmacokinetic characteristics of the test preparation (loratadine tablets, specification 10 mg, licensed by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (loratadine tablets, specification 10 mg, trade name: Claritin, licensed by Bayer Pharmaceuticals (Shanghai) Co., Ltd.) after a single oral administration in healthy subjects under fasting state, compare the bioequivalence of the test preparation and the reference preparation, and study the safety of the drug in healthy subjects.

Start Date15 Feb 2025

Sponsor / Collaborator

Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

100 Clinical Results associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

0 Patents (Medical) associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

100 Deals associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

100 Translational Medicine associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

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Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

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Pipeline Snapshot as of 03 Sep 2025

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