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依帕列净在中国一期临床招募中

时间:2014-07-14  【原创】       阅读

勃林格在中国开展依帕列净针对中国人的一期临床;目前处于招募中;

试验的目的是评估的固定剂量组合依帕列净和二甲双胍片相比,相对与艾帕列净和二甲双胍单独用药的生物利用度;固定组合的片剂将大大加强病人治疗的便利性,特别是在在糖尿病患者需要长期服用药物的情况下。

预计在2014年9月份完成(完成数据收集),目前处于招募中。

来源http://clinicaltrials.gov/ct2/show/study/NCT02102932?term=empagliflozin&rank=20

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.



Condition Intervention Phase

Healthy

Drug: 5 mg empagliflozin/850 mg metformin FDC

Drug: 12.5 mg empagliflozin

Drug: 850 mg metformin

Drug: 5 mg empagliflozin

Drug: 12.5 mg empagliflozin/850 mg metformin FDC

Drug: 12.5 mg empagliflozin/500 mg metformin FDC

Drug: 5 mg empagliflozin/500 mg metformin FDC

Drug: 500 mg metformin

Phase 1


Study Type: Interventional

Study Design: Allocation: Randomized

Endpoint Classification: Pharmacokinetics Study

Intervention Model: Crossover Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title: Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study

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