复方奥美拉唑干混悬剂在健康受试者中单剂量、随机、开放、两序列、两周期、自身交叉空腹状态下的生物等效性试验
[Translation] Bioequivalence study of compound omeprazole dry suspension in single dose, randomized, open, two-sequence, two-period, self-cross fasting state in healthy subjects
研究空腹状态下单次口服受试制剂复方奥美拉唑干混悬剂(规格:奥美拉唑40mg,碳酸氢钠1680mg,浙江同伍生物医药有限公司)与参比制剂复方奥美拉唑干混悬剂(ZEGERID®,规格:奥美拉唑40 mg,碳酸氢钠1680 mg,Salix Pharmaceuticals Inc)在健康成年受试者体内的药代动力学,评价空腹状态下口服两种制剂的生物等效性。
[Translation] Study the test preparation compound omeprazole dry suspension (specification: omeprazole 40mg, sodium bicarbonate 1680mg, Zhejiang Tongwu Biomedical Co., Ltd.) and the reference preparation compound omeprazole under fasting state The pharmacokinetics of dry suspension (ZEGERID®, specification: omeprazole 40 mg, sodium bicarbonate 1680 mg, Salix Pharmaceuticals Inc) in healthy adult subjects, to evaluate the biological effects of the two preparations orally in the fasting state equivalence.
吲哚布芬片在中国健康受试者中随机、开放、两序列、两周期、双交叉空腹
和餐后状态下的生物等效性试验
[Translation] Randomized, open-label, two-sequence, two-period, double-crossover fasting of indobufen tablets in Chinese healthy subjects
and fed state bioequivalence test
主要目的:
1.研究空腹单次口服吲哚布芬片受试制剂(0.2g/片,浙江同伍生物医药有限公司)与
吲哚布芬片参比制剂(200mg/片,持证商:Pfizer Italia S.r.l)后吲哚布芬在中国健康受试
者体内的药代动力学行为,评价空腹口服两种制剂的人体生物等效性。
2.研究餐后单次口服吲哚布芬片受试制剂(0.2g/片,浙江同伍生物医药有限公司)与
吲哚布芬片参比制剂(200mg/片,持证商:Pfizer Italia S.r.l)后吲哚布芬在中国健康受试
者体内的药代动力学行为,评价餐后口服两种制剂的人体生物等效性。
次要目的:
评价中国健康受试者空腹和餐后单次口服吲哚布芬片受试制剂和参比制剂后的安全
性。
[Translation] the main purpose:
1. Study the test preparation (0.2g/tablet, Zhejiang Tongwu Biomedical Co., Ltd.) and
Indobufen Tablets Reference Preparation (200mg/tablet, Licensee: Pfizer Italia S.r.l) After Indobufen was tested in China
The pharmacokinetic behavior in the human body was evaluated to evaluate the human bioequivalence of the two preparations taken orally on an empty stomach.
2. To study the combination of the test preparation of indobufen tablets (0.2g/tablet, Zhejiang Tongwu Biomedical Co., Ltd.) and
Indobufen Tablets Reference Preparation (200mg/tablet, Licensee: Pfizer Italia S.r.l) After Indobufen was tested in China
The pharmacokinetic behavior in the human body was evaluated to evaluate the human bioequivalence of the two preparations after meals.
Secondary purpose:
To evaluate the safety of Chinese healthy volunteers after a single oral administration of indobufen tablets of test and reference preparations on an empty stomach and after a meal
sex.
100 Clinical Results associated with Zhejiang Tongwu Biomedical Co., Ltd.
0 Patents (Medical) associated with Zhejiang Tongwu Biomedical Co., Ltd.
100 Deals associated with Zhejiang Tongwu Biomedical Co., Ltd.
100 Translational Medicine associated with Zhejiang Tongwu Biomedical Co., Ltd.