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Clinical Trials associated with Acetaminophen/Butalbital/Caffeine [Translation] Study on the bioequivalence of Aminophenecato capsules in healthy volunteers
主要研究目的:研究空腹和餐后状态下单次口服受试制剂氨酚咖妥胶囊(规格:布他比妥50mg;对乙酰氨基酚300mg;咖啡因40mg,宜昌人福药业有限责任公司生产)与参比制剂氨酚咖妥胶囊(规格:布他比妥50mg;对乙酰氨基酚300mg;咖啡因40mg;LGM Pharma Solutions, LLC持证)在健康研究参与者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂氨酚咖妥胶囊和参比制剂氨酚咖妥胶囊在健康研究参与者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation Aminocafe Capsules (specifications: butalbital 50 mg; acetaminophen 300 mg; caffeine 40 mg, produced by Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation Aminocafe Capsules (specifications: butalbital 50 mg; acetaminophen 300 mg; caffeine 40 mg; licensed by LGM Pharma Solutions, LLC) in healthy study participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting and fed state.
Secondary purpose of the study is to study the safety of the test preparation Aminocafe Capsules and the reference preparation Aminocafe Capsules in healthy study participants.
[Translation] Study on the bioequivalence of Aminophenecato capsules in healthy volunteers
主要研究目的:研究空腹状态下单次口服受试制剂氨酚咖妥胶囊(规格:布他比妥50mg;对乙酰氨基酚300mg;咖啡因40mg,宜昌人福药业有限责任公司生产)与参比制剂氨酚咖妥胶囊(商品名:Fioricet,规格:布他比妥50mg;对乙酰氨基酚300mg;咖啡因40mg;Nexgen Pharma,Inc生产)在健康受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂氨酚咖妥胶囊和参比制剂氨酚咖妥胶囊(Fioricet®)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation Aminocafe Capsules (specifications: butalbital 50 mg; acetaminophen 300 mg; caffeine 40 mg, produced by Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation Aminocafe Capsules (trade name: Fioricet, specifications: butalbital 50 mg; acetaminophen 300 mg; caffeine 40 mg; produced by Nexgen Pharma, Inc) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions.
Secondary purpose of the study: to study the safety of the test preparation Aminocafe Capsules and the reference preparation Aminocafe Capsules (Fioricet®) in healthy subjects.
[Translation] Bioequivalence study of acetaminophen capsules in humans (formal trial)
主要研究目的:研究空腹和餐后状态下单次口服受试制剂氨酚咖妥胶囊(规格:布他比妥50mg;对乙酰氨基酚300mg;咖啡因40mg,宜昌人福药业有限责任公司生产)与参比制剂氨酚咖妥胶囊(Fioricet,规格:布他比妥50mg;对乙酰氨基酚300mg;咖啡因40mg;Nexgen Pharma,Inc生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂氨酚咖妥胶囊和参比制剂氨酚咖妥胶囊(Fioricet)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation Aminocafetol Capsules (specifications: butalbital 50 mg; acetaminophen 300 mg; caffeine 40 mg, produced by Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation Aminocafetol Capsules (Fioricet, specifications: butalbital 50 mg; acetaminophen 300 mg; caffeine 40 mg; produced by Nexgen Pharma, Inc) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study: to study the safety of the test preparation Aminocafetol Capsules and the reference preparation Aminocafetol Capsules (Fioricet) in healthy subjects.
100 Clinical Results associated with Acetaminophen/Butalbital/Caffeine
100 Translational Medicine associated with Acetaminophen/Butalbital/Caffeine
100 Patents (Medical) associated with Acetaminophen/Butalbital/Caffeine
100 Deals associated with Acetaminophen/Butalbital/Caffeine