NCT02171481已完成1 期
Bioequivalence of Two Different Polymorphs of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover 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
- 66
- 主要终点
- Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II
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
- Double
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- •Age ≥60 and ≤85 years
- •BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
排除标准
- •Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Clinically relevant surgery of gastrointestinal tract
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Any relevant bleeding history
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •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
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
- •Alcohol abuse (more than 60 g/day for men and more than 40 g/day for women)
- •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 study centre
- •Planned surgeries within four weeks following the end-of study examination
- •Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, coumarin etc. within 10 days prior to administration
- •Male subjects who do not agree to minimise the risk of female partners becoming pregnant from the first dosing day until the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
研究组 & 干预措施
Dabigatran etexilate polymorph II
Experimental
干预措施: Dabigatran etexilate polymorph II (Drug)
Dabigatran etexilate polymorph I
Active Comparator
干预措施: Dabigatran etexilate polymorph I (Drug)
结局指标
主要结局
Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to 72 hours after drug administration
Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax)
时间窗: Up to 72 hours after drug administration
次要结局
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(Up to 72 hours after drug administration)
- Terminal rate constant in plasma (λz)(Up to 72 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(Up to 72 hours after drug administration)
- Change from baseline in physical examination(Baseline, day 68)
- Change from baseline in vital signs (blood pressure, pulse rate)(Baseline, day 68)
- Change from baseline in 12-lead electrocardiogram(Baseline, day 68)
- Change from baseline in clinical laboratory tests(Baseline, day 68)
- Number of Participants with Serious and Non-Serious Adverse Events(up to day 68)
- Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)(Day 68)
- Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 72 hours after drug administration)
- Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax)(Up to 72 hours after drug administration)
- 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 (AUC0-tz)(Up to 72 hours after drug administration)
- Mean residence time of the analyte in the body after oral administration (MRTpo)(Up to 72 hours after drug administration)
- Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)(Up to 72 hours after drug administration)
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F )(Up to 72 hours after drug administration)
- Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours (AUCt1-t2)(24, 48 and 72 hours after drug administration)
研究者
相似试验
已完成
1 期
Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female VolunteersHealthyNCT02171013Boehringer Ingelheim66
尚未招募
1 期
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting ConditionsHealthy VolunteerDabigatranBioequivalence StudyNCT06441916International Bio service60
已完成
1 期
Bioequivalence of Two Different Capsule Types of DabigatranHealthyNCT01290757Boehringer Ingelheim180
已完成
1 期
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed ConditionsHealthy Subjects in Fasted and Fed StateNCT03216278AstraZeneca284
已完成
1 期
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy SubjectsBioequivalenceFixed Dose Combination TabletsHealthy Male and Female SubjectsNCT02637037AstraZeneca80