Clinical trial NCT02218684: Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects
Official title: Tolerability and Pharmacokinetics of 80 mg Telmisartan in Combination With 2, 4, or 6 mg Lacidipine. An Open, Single Rising Dose Group Comparison Trial - Placebo Randomised Double Blind in Each Dose Group - in Male Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 72 hours after drug administration
Secondary outcomes:
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
timeFrame: up to 72 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 72 hours after drug administration
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
timeFrame: up to 72 hours after drug administration
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
timeFrame: up to 72 hours after drug administration
measure: MRT (Mean residence time of the analyte in the body)
timeFrame: up to 72 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: up to 72 hours after drug administration
Other outcomes:
Locations:
Study officials:
References: