NCT02172222已完成1 期
Relative Bioavailability of Multiple Doses BI 10773 50 mg and Linagliptin 5 mg After Concomitant Administration Compared to Multiple Doses of BI 10773 50 mg and Linagliptin 5mg Administered Alone to Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
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
- 16
- 主要终点
- AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
研究概览
简要总结
Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers according to the following criteria:
- •Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests
- •Age 18 to 50 years (inclusive)
- •BMI 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) 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/hypersensitivity (including allergy to drug or its excipients)
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- •Participation in another trial with an investigational drug within two months prior to administration or during the trial
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (more than 30 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
研究组 & 干预措施
Sequence CAB
Experimental
- Treatment C: Linagliptin once daily from day 1 to 7
- Treatment A: BI 10773 once daily from day 1 to 5
- Treatment B: BI10773 and linagliptin once daily from day 1 to 7
干预措施: Linagliptin (Drug)
Sequence ABC
Experimental
- Treatment A: BI 10773 once daily from day 1 to 5
- Treatment B: BI10773 and linagliptin once daily from day 1 to 7
- Treatment C: Linagliptin once daily from day 1 to 7
干预措施: BI 10773 (Drug)
Sequence ABC
Experimental
- Treatment A: BI 10773 once daily from day 1 to 5
- Treatment B: BI10773 and linagliptin once daily from day 1 to 7
- Treatment C: Linagliptin once daily from day 1 to 7
干预措施: Linagliptin (Drug)
Sequence CAB
Experimental
- Treatment C: Linagliptin once daily from day 1 to 7
- Treatment A: BI 10773 once daily from day 1 to 5
- Treatment B: BI10773 and linagliptin once daily from day 1 to 7
干预措施: BI 10773 (Drug)
结局指标
主要结局
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
时间窗: up to day 8
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
时间窗: up to day 8
次要结局
- tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state)(up to day 8)
- Urine glucose excretion (UGE)(Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit)
- Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition(2 hours and 24 hours after last administration of study drug)
- Changes from baseline in physical examination(Baseline and within 5 days after last study drug administration)
- Changes from baseline in vital signs (blood pressure, pulse rate)(Baseline, day 1 and within 5 days after last study drug administration)
- Changes from baseline in 12-lead ECG (electrocardiogram)(Baseline and within 5 days after last study drug administration)
- Changes from baseline clinical laboratory tests(Baseline, day 1 and within 5 days after last study drug administration)
- Incidence of adverse events(Up to 56 days)
- Assessment of tolerability by investigator on a 4-point scale(Within 5 days after last study drug administration)
研究者
相似试验
已完成
1 期
Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male VolunteersHealthyNCT02172261Boehringer Ingelheim16
已完成
1 期
Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy VolunteersHealthyNCT01301742Boehringer Ingelheim18
已完成
1 期
Bioavailability of BI 10773 and Pioglitazone in Healthy Male VolunteersHealthyNCT02276365Boehringer Ingelheim20
已完成
1 期
Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy VolunteersHealthyNCT02172235Boehringer Ingelheim20
已完成
1 期
Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy VolunteersHealthyNCT01284621Boehringer Ingelheim23