Bioavailability of Lacidipine 4 mg and Telmisartan 40 mg Administered Orally as Two Experimental Fixed Dose Combination Tablets Relative to Separate Tablets. An Open Randomised Three-way Cross-over Steady State Trial in 6 Female and 6 Male Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Number of patients with abnormal changes in laboratory parameters
研究概览
简要总结
Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female Caucasian subjects as determined by results of screening
- •Age ≥ 18 and ≤ 50 years
- •Broca ≥ - 20 % and ≤ + 20 %
- •Written informed consent in accordance with Good Clinical Practice and local legislation given
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
- •History of 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) (≤ 1 month prior to administration or during the trial, except for oral contraceptives)
- •Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
- •Participation in another trial with an investigational drug (≤ 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 (> 60 g/day)
- •Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
- •Excessive physical activities (≤ 10 days prior to administration or during the trial)
- •Any laboratory value outside the reference range of clinical relevance
- •Females only:
- •no reliable contraception (e.g. oral contraceptives, 3-month injection, intrauterine device, sterilisation)
- •pregnancy of breast feeding period
研究组 & 干预措施
Telmisartan and Lacidipine FDC, formulation A
干预措施: Lacidipine and Telmisartan fixed dose combination (FDC) tablet (Drug)
Telmisartan and Lacidipine FDC, formulation B
干预措施: Lacidipine and Telmisartan fixed dose combination (FDC) tablet (Drug)
Lacidipine and Telmisartan, mono
干预措施: Lacidipine (Drug)
Lacidipine and Telmisartan, mono
干预措施: Telmisartan (Drug)
结局指标
主要结局
Number of patients with abnormal changes in laboratory parameters
时间窗: up to 66 days
Mean residence time (MRTss)
时间窗: up to 72 hours after drug administration at day 7
Number of patients with clinically relevant changes in electrocardiogram
时间窗: up to 66 days
Number of patients with adverse events
时间窗: up to 66 days
Assessment of tolerability on a verbal rating scale
时间窗: between day 3 and 5 after last study drug administration
Area under the curve at steady state (AUCss)
时间窗: up to 72 hours after drug administration at day 7
Time to maximum concentration (tmax)
时间窗: up to 72 hours after drug administration at day 7
Terminal half-life (t1/2)
时间窗: up to 72 hours after drug administration at day 7
Number of patients with clinically relevant changes in vital signs
时间窗: up to 66 days
Maximum concentration (Cmax,ss)
时间窗: up to 72 hours after drug administration at day 7
Total apparent clearance (CLtot/f)
时间窗: up to 72 hours after drug administration at day 7
Apparent volume of distribution (Vz/f)
时间窗: up to 72 hours after drug administration at day 7
Number of patients with abnormal findings in physical examination
时间窗: up to 66 days
次要结局
未报告次要终点