中国健康受试者餐后状态下单次给予丁二磺酸腺苷蛋氨酸肠溶片的随机、开放、四周期重复交叉设计的生物等效性试验
[Translation] A randomized, open-label, four-cycle repeated crossover design bioequivalence trial of adenosylmethionine butisulfonate enteric-coated tablets administered to Chinese healthy subjects after a meal in a single dose
主要研究目的
研究餐后状态下单次口服受试制剂丁二磺酸腺苷蛋氨酸肠溶片(规格:0.5g,由注册申请人杭州沐源生物医药科技有限公司提供(生产厂家:江苏和晨药业有限公司))与参比制剂丁二磺酸腺苷蛋氨酸肠溶片(思美泰®,规格:0.5g;ABBVIE S.R.L生产,杭州沐源生物医药科技有限公司提供)在健康成年受试者体内的药代动力学,评价餐后状态口服两种制剂的生物等效性。
次要研究目的
研究受试制剂丁二磺酸腺苷蛋氨酸肠溶片和参比制剂丁二磺酸腺苷蛋氨酸肠溶片(思美泰®)在健康成年受试者中的安全性。
[Translation] Main research purpose
Study the single oral administration of the test preparation adenosylmethionine butisulfonate enteric-coated tablets in the postprandial state (specification: 0.5g, provided by registered applicant Hangzhou Muyuan Biomedical Technology Co., Ltd. (manufacturer: Jiangsu Hechen Pharmaceutical Co., Ltd. company)) and the reference preparation adenosine methionine butanedisulfonate enteric-coated tablets (Simeitai®, specification: 0.5g; produced by ABBVIE S.R.L, provided by Hangzhou Muyuan Biomedical Technology Co., Ltd.) in healthy adult subjects Pharmacokinetics, to evaluate the bioequivalence of two formulations taken orally in the postprandial state.
Secondary research purpose
To study the safety of the test preparation adenosylmethionine succinate enteric-coated tablets and the reference preparation adenosylmethionine succinate enteric-coated tablets (Simeita®) in healthy adult subjects.
[Translation] Study on human bioequivalence of sulindac tablets
主要研究目的:研究空腹及餐后给药条件下,杭州沐源生物医药科技有限公司提供的舒林酸片(200 mg)与 WATSON LABORATORIES INC 持证的舒林酸片(200 mg,商品名:Sulindac®)在中国健康受试者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的:评价杭州沐源生物医药科技有限公司提供的舒林酸片(200 mg)与 WATSON LABORATORIES INC 持证的舒林酸片(200 mg,商品名:Sulindac®)在中国健康受试者中的安全性。
[Translation] Main research purpose: To study the sulindac tablets (200 mg) provided by Hangzhou Muyuan Biomedical Technology Co., Ltd. and the certified sulindac tablets (200 mg, trade name: Pharmacokinetics of Sulindac®) in Chinese healthy subjects to evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states. Secondary research purpose: To evaluate the health trials in China of sulindac tablets (200 mg) provided by Hangzhou Muyuan Biomedical Technology Co., Ltd. and sulindac tablets (200 mg, trade name: Sulindac®) certified by WATSON LABORATORIES INC. safety among the users.
美阿沙坦钾片在健康受试者中空腹/餐后状态下的开放、随机、交叉生物等效性试验
[Translation] An open-label, randomized, crossover bioequivalence trial of Measartan Potassium Tablets in healthy subjects under fasting/postprandial conditions
主要试验目的:
研究空腹/餐后状态下单次口服受试制剂美阿沙坦钾片(规格:80mg,华益药业科技(安徽)有限公司生产)与参比制剂美阿沙坦钾片(商品名易达比®,规格:80mg;Takeda Ireland Ltd.生产)在健康受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
次要试验目的:
评估受试制剂美阿沙坦钾片(规格:80mg)与参比制剂易达比®(规格:80mg)在健康受试者中的安全性。
[Translation] Main test purpose:
Study the single oral administration of the test preparation Measartan Potassium Tablets (specification: 80 mg, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation Measartan Potassium Tablets (trade name Yidabi) in the fasting/postprandial state. ®, strength: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects to evaluate the bioequivalence of the two oral formulations in the fasting/postprandial state.
Secondary test purpose:
To evaluate the safety of the test preparation Measartan Potassium Tablets (specification: 80 mg) and the reference preparation Yidabi® (specification: 80 mg) in healthy subjects.
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