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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date19 Aug 1966 |
/ Active, not recruitingNot Applicable 盐酸那拉曲坦片随机、开放、两周期、两交叉健康人体空腹/餐 后状态下生物等效性试验--预试验
[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of naratriptan hydrochloride tablets in healthy volunteers in the fasting/fed state - a pilot study
通过健康受试者在空腹和餐后状态下分别单次口服由江苏美通制药有限公司提供的受试制剂盐酸那拉曲坦片(规格:2.5mg)与参比制剂盐酸那拉曲坦片(商品名:AMERGE,规格:2.5mg),进行人体相对生物利用度研究,评价受试制剂与参比制剂的生物等效性。根据安全性指标变化情况评估盐酸那拉曲坦片的安全性。
[Translation] The relative bioavailability of the test preparation, naratriptan hydrochloride tablets (specification: 2.5 mg) and the reference preparation, naratriptan hydrochloride tablets (trade name: AMERGE, specification: 2.5 mg), provided by Jiangsu Meitong Pharmaceutical Co., Ltd., was studied by taking a single oral dose in the fasting and postprandial state in healthy subjects to evaluate the bioequivalence of the test preparation and the reference preparation. The safety of naratriptan hydrochloride tablets was evaluated based on the changes in safety indicators.
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