依帕列净在中国一期临床招募中
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