/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of flurbiprofen gel patch in healthy individuals
以健康参与者为研究对象,以福元药业有限公司研制的氟比洛芬凝胶贴膏为受试制剂,以MIKASA SEIYAKU CO.,LTD KAKEGAWA FACTORY生产的氟比洛芬凝胶贴膏为参比制剂,比较两种制剂在健康参与者体内的吸收速度和吸收程度,评价两种制剂的生物等效性。观察受试制剂氟比洛芬凝胶贴膏和参比制剂氟比洛芬凝胶贴膏在中国健康参与者中的安全性、皮肤反应性和黏附性。
[Translation] This study used healthy participants as research subjects, with flurbiprofen gel patch developed by Fuyuan Pharmaceutical Co., Ltd. as the test formulation and flurbiprofen gel patch manufactured by MIKASA SEIYAKU CO.,LTD KAKEGAWA FACTORY as the reference formulation. The absorption rate and extent of absorption of the two formulations in healthy participants were compared, and their bioequivalence was evaluated. The safety, skin reactivity, and adhesion of the test and reference formulations of flurbiprofen gel patch were observed in healthy Chinese participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of ketoprofen gel patch in healthy individuals
以健康参与者为研究对象,以福元药业有限公司生产的酮洛芬凝胶贴膏(规格:每贴(10 cm×14 cm)含膏体10 g,含酮洛芬30 mg)为受试制剂,以久光製薬株式会社生产的酮洛芬凝胶贴膏(商品名:MOHRUS®Paps,规格:30 mg,10 cm×14 cm)为参比制剂,比较两种制剂在健康参与者体内的吸收速度和吸收程度,评价两种制剂的生物等效性。观察受试制剂酮洛芬凝胶贴膏和参比制剂酮洛芬凝胶贴膏在中国健康参与者中的安全性、皮肤反应性和黏附性。
[Translation] This study used healthy participants as subjects. Ketoprofen gel patches (10 g of gel per patch (10 cm × 14 cm), containing 30 mg of ketoprofen) manufactured by Fukuhara Pharmaceutical Co., Ltd. were used as the test formulation. Ketoprofen gel patches (MOHRUS® Paps, 30 mg, 10 cm × 14 cm), manufactured by Hisamitsu Pharmaceutical Co., Ltd., were used as the reference formulation. The absorption rate and extent of absorption of the two formulations in healthy participants were compared, and their bioequivalence was evaluated. The safety, skin reactivity, and adhesion of the test and reference formulations of ketoprofen gel patches were observed in healthy Chinese participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of diclofenac diethylamine latex in healthy individuals
主要研究目的:
以健康参与者为研究对象,以福元药业有限公司生产、持有的双氯芬酸二乙胺乳胶剂2%(50 g:1.0 g,以双氯芬酸钠计))为受试制剂,以Haleon CH SARL生产,Haleon Schweiz AG持证的双氯芬酸二乙胺乳胶剂(商品名:扶他林 ®,规格:2% (50克:1.0克,以双氯芬酸钠计))为参比制剂,比较两种制剂在健康参与者中的药代动力学,评价两种制剂的生物等效性。 次要研究目的:
(1)观察受试制剂双氯芬酸二乙胺乳胶剂和参比制剂双氯芬酸二乙胺乳胶剂在健康参与者中的安全性;
(2)评价受试制剂双氯芬酸二乙胺乳胶剂和参比制剂双氯芬酸二乙胺乳胶剂在健康参与者中的皮肤反应性。
[Translation] Primary Objective: Using healthy participants as subjects, this study compared the pharmacokinetics of diclofenac diethylamine emulsion 2% (50 g: 1.0 g, based on diclofenac sodium) manufactured and licensed by Fuyuan Pharmaceutical Co., Ltd., as the test formulation, and the bioequivalence of diclofenac diethylamine emulsion manufactured by Haleon CH SARL and licensed by Haleon Schweiz AG (trade name: Voltaren®, specification: 2% (50 g: 1.0 g, based on diclofenac sodium)) as the reference formulation. Secondary Objectives:
(1) To observe the safety of the test formulation diclofenac diethylamine emulsion and the reference formulation diclofenac diethylamine emulsion in healthy participants;
(2) To evaluate the skin reactivity of the test formulation diclofenac diethylamine emulsion and the reference formulation diclofenac diethylamine emulsion in healthy participants.
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