茶碱缓释片在健康受试者中随机、开放、两制剂、四周期、完全重复交叉空腹及餐后条件下的生物等效性试验
[Translation] A randomized, open-label, two-preparation, four-cycle, fully repeated cross-over fasting and postprandial bioequivalence trial of theophylline extended-release tablets in healthy subjects
主要研究目的:本研究考察健康受试者在空腹及餐后条件下,单次口服由湖南绅泰春制药股份有限公司提供的茶碱缓释片(受试制剂,规格:100mg)与相同条件下单次口服由日医工株式会社持证的茶碱缓释片(参比制剂R,商品名:UNICONTM,规格:100mg)的药动学特征,评价两制剂间的生物等效性,为受试制剂的一致性评价提供依据。
次要研究目的:观察健康受试者在空腹及餐后条件下单次口服100mg的受试制剂茶碱缓释片(规格:100mg)与参比制剂茶碱缓释片(商品名:UNICONTM,规格:100mg)的安全性
[Translation] Main research purpose: This study investigates whether healthy subjects take a single oral administration of theophylline sustained-release tablets (test preparation, specification: 100 mg) provided by Hunan Shentaichun Pharmaceutical Co., Ltd. under fasting and postprandial conditions and the same conditions. The pharmacokinetic characteristics of theophylline sustained-release tablets (reference preparation R, trade name: UNICONTM, specification: 100mg) certified by Nippon Medical Industry Co., Ltd. were taken orally in a single dose, and the bioequivalence between the two preparations was evaluated. Provide a basis for the consistency evaluation of test preparations.
Secondary research purpose: To observe the oral administration of 100 mg of the test preparation theophylline sustained-release tablets (specification: 100mg) and the reference preparation theophylline sustained-release tablets (trade name: UNICONTM, Specification: 100mg) safety
茶碱缓释片在健康受试者中随机、开放、两制剂、四周期、完全重复交叉空腹及餐后条件下的生物等效性试验
[Translation] Bioequivalence study of theophylline sustained-release tablets in healthy subjects in a randomized, open-label, two-drug, four-cycle, fully repeated crossover fasting and postprandial condition
主要研究目的 本研究考察健康受试者在空腹及餐后条件下,单次口服由湖南绅泰春制药股份有限公司生产的茶碱缓释片(受试制剂,规格:100mg)与相同状态下单次口服由日医工株式会社持证的茶碱缓释片(参比制剂R,商品名:UNICONTM,规格:100mg)的药动学特征,评价两制剂间的生物等效性,为受试制剂的一致性评价提供依据。 次要研究目的 观察健康受试者在空腹及餐后条件下单次口服100mg的受试制剂茶碱缓释片(规格:100mg)与参比制剂茶碱缓释片(商品名:UNICONTM,规格:100mg)的安全性。
[Translation] Main research purpose This study investigated healthy subjects taking a single oral dose of theophylline sustained-release tablets (test preparation, specification: 100 mg) produced by Hunan Shentaichun Pharmaceutical Co., Ltd. The pharmacokinetic characteristics of theophylline sustained-release tablets (reference preparation R, trade name: UNICONTM, specification: 100 mg) certified by Nippon Medical Industry Co., Ltd. after a single oral administration, and the bioequivalence between the two preparations was evaluated. The consistency evaluation of preparations provides the basis. Secondary research objective To observe healthy subjects taking 100 mg of the test preparation theophylline sustained-release tablets (specification: 100 mg) and the reference preparation theophylline sustained-release tablets (trade name: UNICONTM, specification) under fasting and postprandial conditions. : 100mg) safety.
茶碱缓释片在健康受试者中随机、开放、两制剂、四周期、完全重复交叉空腹及餐后条件下的生物等效性试验
[Translation] Bioequivalence study of theophylline sustained-release tablets in healthy subjects in a randomized, open-label, two-drug, four-cycle, fully repeated crossover fasting and postprandial condition
主要研究目的
本研究考察健康受试者在空腹及餐后条件下,单次口服由湖南绅泰春制药股份有限公司生产的茶碱缓释片(受试制剂,规格:100mg)与相同状态下单次口服由日医工株式会社持证的茶碱缓释片(参比制剂R,商品名:UNICONTM,规格:100mg)的药动学特征,评价两制剂间的生物等效性,为受试制剂的一致性评价提供依据。
次要研究目的
观察健康受试者在空腹及餐后条件下单次口服100mg的受试制剂茶碱缓释片(规格:100mg)与参比制剂茶碱缓释片(商品名:UNICONTM,规格:100mg)的安全性。
[Translation] Main research purpose
In this study, healthy subjects took a single oral dose of theophylline sustained-release tablets (test preparation, specification: 100 mg) produced by Hunan Shentaichun Pharmaceutical Co. The pharmacokinetic characteristics of theophylline sustained-release tablets (reference formulation R, trade name: UNICONTM, specification: 100 mg) certified by Nippon Medical Industry Co., Ltd., and the bioequivalence between the two formulations was evaluated, which was consistent with the tested formulations provide the basis for evaluation.
Secondary research purpose
Observe the difference between the test preparation theophylline sustained-release tablet (specification: 100mg) and the reference preparation theophylline sustained-release tablet (trade name: UNICONTM, specification: 100mg) when healthy subjects take a single oral dose of 100mg under fasting and postprandial conditions. safety.
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