Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects
- Registration Number
- NCT02203500
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Healthy male and female Caucasian subjects as determined by results of screening
- Written informed consent in accordance with Good Clinical Practice and local legislation given
- Age >= 18 and <= 50 years
- Broca >= -20% and <= + 20%
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Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
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Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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Surgery of gastrointestinal tract (except appendectomy)
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Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
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History of orthostatic hypotension, fainting spells or blackouts
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Chronic or relevant acute infections
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History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
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Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
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Participation in another trial with an investigational drug (<= 2 months prior to administration or during the trial)
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Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
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Inability to refrain from smoking on study days
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Alcohol abuse (> 60g/day)
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Drug abuse
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Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial)
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Any laboratory value outside the reference range of clinical relevance
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Female only:
- no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)
- Pregnancy or breast feeding period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lacidipine + Telmisartan Lacidipine - Lacidipine + Telmisartan Telmisartan - Lacidipine Lacidipine - Telmisartan Telmisartan -
- Primary Outcome Measures
Name Time Method Cmax (Maximum measured concentration of the analyte in plasma) up to 72 hours after drug administration Cmin (Minimum measured concentration of the analyte in plasma) up to 72 hours after drug administration Number of subjects with clinically significant changes in vital signs up to 12 days after last drug administration Number of subjects with abnormal changes in laboratory parameters up to 12 days after last drug administration AUCss (Area under the concentration-time curve of the analyte in plasma at steady state) up to 72 hours after drug administration t½ (Terminal half-life of the analyte in plasma) up to 72 hours after drug administration tmax (Time from dosing to the maximum concentration of the analyte in plasma) up to 72 hours after drug administration CL/F (Apparent clearance of the analyte in plasma following extravascular administration) ) up to 72 hours after drug administration Vz/F (Apparent volume of distribution of the analyte during the terminal phase) up to 72 hours after drug administration MRT (Mean residence time of the analyte in the body) up to 72 hours after drug administration Number of subjects with adverse events up to 66 days
- Secondary Outcome Measures
Name Time Method