NCT02220647已完成1 期
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets Administered Together in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover, Phase I Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)
研究概览
简要总结
Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850 mg administered together
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead ECG, clinical laboratory tests
- •Age 18 to 55 years (inclusive)
- •Body mass index (BMI) 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
排除标准
- •Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- •Any evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
- •Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
- •Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- •Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
- •Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
- •Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
- •Any laboratory value outside the reference range of clinical relevance
- •Inability to comply with dietary regimen of trial site
- •For female subjects of childbearing potential only:
- •Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
- •No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilization (including hysterectomy). Women who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were asked to use an additional barrier method (e.g. condom).
研究组 & 干预措施
Treatment A (FDC)
Experimental
干预措施: Linagliptin/Metformin FDC (Drug)
Treatment B (single agents)
Active Comparator
干预措施: Linagliptin (Drug)
Treatment B (single agents)
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)
时间窗: up to 72 hours
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 72 hours
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 72 hours
次要结局
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 72 hours)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(up to 72 hours)
- λz (terminal elimination rate constant in plasma)(up to 72 hours)
- t1/2 (terminal half-life of the analyte in plasma)(up to 72 hours)
- MRTpo (mean residence time of the analyte in the body after peroral administration)(up to 72 hours)
- AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)(up to 72 hours)
- %AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation)(up to 72 hours)
- AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)(up to 72 hours)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(up to 72 hours)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 72 hours)
- Assessment of tolerability by investigator on a 4-point scale(up to 7 days after drug administration)
- Number of subjects with clinically significant findings in vital signs(up to 7 days after drug administration)
- Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG)(up to 7 days after drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 7 days after drug administration)
- Number of subjects with adverse events(up to 7 days after drug administration)
研究者
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