Clinical trial NCT02203500: Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects
Official title: Tolerability and Pharmacokinetics of 80 mg Telmisartan and 6 mg Lacidipine Alone and in Combination After 7 Days Treatment. An Open Randomised Three-way Cross-over Trial in Female and Male Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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%

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)
* Any laboratory value outside the reference range of clinical relevance
* Female only:

  * no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)
  * Pregnancy or breast feeding period

Primary outcomes:
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: up to 12 days after last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to 12 days after last drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 72 hours after drug administration
measure: Cmin (Minimum measured concentration of the analyte in plasma)
timeFrame: up to 72 hours after drug administration
measure: AUCss (Area under the concentration-time curve of the analyte in plasma at steady state)
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: t½ (Terminal half-life of the analyte in plasma)
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: Number of subjects with adverse events
timeFrame: up to 66 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: