Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects
- Registration Number
- NCT02218684
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
Inclusion Criteria
- Healthy male 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%
Exclusion Criteria
- Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases 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)
- Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
- 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 study days
- Alcohol abuse (> 60g/day)
- Drug abuse
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Telmisartan + Lacidipine - high dose Telmisartan - Telmisartan + Lacidipine - low dose Telmisartan - Telmisartan + Lacidipine - medium dose Lacidipine - Telmisartan + Lacidipine - medium dose Telmisartan - Telmisartan + Lacidipine - low dose Lacidipine - Telmisartan + Lacidipine - high dose Lacidipine -
- Primary Outcome Measures
Name Time Method Cmax (Maximum measured concentration of the analyte in plasma) up to 72 hours after drug administration Number of subjects with adverse events up to 72 hours after drug administration
- Secondary Outcome Measures
Name Time Method AUC (Area under the concentration-time curve 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 t½ (Terminal half-life of the analyte in plasma) up to 72 hours after drug administration Number of subjects with abnormal changes in laboratory parameters up to 72 hours after drug administration Number of subjects with clinically significant changes in vital signs up to 72 hours after drug administration