Investigation of the Effect of BI 764198 on the Pharmacokinetics of Metformin Following Multiple Oral Administration in Healthy Male and Female Trial Participants (an Open-label, Randomised, Two-way Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Metformin: Area under the concentration-time (AUC) curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
研究概览
简要总结
The main objective of this trial is to investigate the effect on the exposure of metformin in plasma when administered as an oral multiple dose together with multiple oral doses of BI 764198 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure [BP], Pulse rate [PR]), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
- •Age of 18 to 55 years (inclusive).
- •BMI of 18.5 to 29.9 kg / m² (inclusive).
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimeters of mercury (mmHg), or pulse rate outside the range of 50 to 90 beat per minute (bpm).
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- •Further exclusion criteria apply.
研究组 & 干预措施
Reference - Treatment (R-T)
This arm starts with the reference treatment (R), metformin hydrochloride, followed by a washout period, and then the test treatment (T), metformin hydrochloride and BI 764198.
干预措施: Metformin hydrochloride (Drug)
Reference - Treatment (R-T)
This arm starts with the reference treatment (R), metformin hydrochloride, followed by a washout period, and then the test treatment (T), metformin hydrochloride and BI 764198.
干预措施: BI 764198 (Drug)
Treatment - Reference (T-R)
This arm starts with the test treatment (T), metformin hydrochloride and BI 764198, followed by a washout period, and then the reference treatment (R), metformin hydrochloride.
干预措施: Metformin hydrochloride (Drug)
Treatment - Reference (T-R)
This arm starts with the test treatment (T), metformin hydrochloride and BI 764198, followed by a washout period, and then the reference treatment (R), metformin hydrochloride.
干预措施: BI 764198 (Drug)
结局指标
主要结局
Metformin: Area under the concentration-time (AUC) curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
时间窗: Up to 5 days
Metformin: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
时间窗: Up to 5 days
次要结局
- Metformin: Renal clearance of the analyte from plasma at steady state (CL R,ss)(Up to 5 days)