NCT02183636已完成1 期
Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin 5 mg/Pioglitazone 45 mg Compared With Single Linagliptin 5 mg and Pioglitazone 45 mg Tablets Administered Together to Healthy Male and Female Subjects (Open, Randomised, Single Dose, Three-period 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
- 39
- 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
Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects according to the following criteria: based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- •Age ≥18 and ≤55 years
- •Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
- •Signed and dated written informed consent prior to admission to the study, in accordance with 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), 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 h) within at least 1 month or less than 10 halflives of the respective drug prior to administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial or 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 2 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 for males and 20 g/day for females)
- •Drug abuse
- •Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- •Excessive physical activities (within 1 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
- •For female subjects:
- •Pregnancy or a positive pregnancy test, planning to become pregnant during the study, or within 1 month of study completion or lactation period
- •No adequate contraception during the study and until 1 month after study completion, i.e. implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month before enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females who did not have a vasectomised partner, were not sexually abstinent, or were not surgically sterile were asked to additionally use barrier contraception methods (i.e. condom, diaphragm with spermicide)
- •For male subjects:
- •Male subjects who did 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 included barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least 2 months)
研究组 & 干预措施
Treatment 1 (T1)
Experimental
Linagliptin/pioglitazone, FDC formulation C5
干预措施: Linagliptin/pioglitazone, FDC formulation C5 (Drug)
Treatment 2 (T2)
Experimental
Linagliptin/pioglitazone, FDC formulation C8
干预措施: Linagliptin/pioglitazone, FDC formulation C8 (Drug)
Reference (R)
Active Comparator
Linagliptin tablet and pioglitazone tablet (Actos®)
干预措施: Linagliptin tablet (Drug)
Reference (R)
Active Comparator
Linagliptin tablet and pioglitazone tablet (Actos®)
干预措施: pioglitazone tablet (Actos®) (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: 1 hour prior drug administration and up to 120 h after drug administration
Cmax (maximum measured concentration of linagliptin in plasma)
时间窗: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 extrapolated to infinity)
时间窗: 1 hour prior drug administration and up to 72 h after drug administration
Cmax (maximum measured concentration of pioglitazone in plasma)
时间窗: 1 hour prior drug administration and up to 72 h after drug administration
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)(1 hour prior drug administration and up to 120 h after drug administration)
- AUC0-infinity (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)(1 hour prior drug administration and up to 120 h after drug administration)
- AUC0-72 (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 to 72 h)(1 hour prior drug administration and up to 72 after drug administration)
- Changes from baseline in vital signs (blood pressure (BP) and pulse rate (PR))(21 to 1 day prior start of treatment, at study visits 2 to 4 (prior to treatment administration and 24 h following treatment administration), and 7 days after last treatment administration)
- Occurrence of adverse events (AEs)(until 7 days after last treatment administration)
- Assessment of tolerability by the investigator(on day 6 of each treatment and 7 days after last treatment administration)
研究者
相似试验
已完成
1 期
Bioavailability of Combination Tablet BI 1356/Metformin Compared With Single BI 1356 and Metformin Administered Together to Healthy Male and Female SubjectsHealthyNCT02173639Boehringer Ingelheim20
已完成
1 期
A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy VolunteersHealthyNCT01692834NeuroVive Pharmaceutical AB65
已完成
1 期
Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male VolunteersHealthyNCT02195804Boehringer Ingelheim42
已完成
1 期
Topiramate Bioequivalence Study Brazil - FastEpilepsy, Tonic-ClonicNCT01439438GlaxoSmithKline26
进行中（未招募）
1 期
A study in healthy people to compare 2 different formulations of nerandomilast tablets when taken with or without foodHealthy volunteer trialCTIS2024-511245-18-00Boehringer Ingelheim International GmbH15