Healthy
Conditions
Brief summary
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
All participants in the study should be healthy males/females, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2. In accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.
Exclusion criteria
* Any finding of the medical examination (including blood pressure, heart rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * Participation in another tiral with an investigational drug (\<= two 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) * Drug abuse * Blood donation (\>= 100 ml within four weeks prior to administration or during the trial) * Any laboratory value outside the clinically accepted reference range * Excessive physical activities within the last week before the trial or during the trial Following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average QTcF (QT interval Fridericia correction) change | baseline, day 1, day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QTcB (QT interval Bazett correction) interval | baseline, day 1, day 7 | — |
| Change in PQ interval | baseline, day 1, day 7 | — |
| Change in QRS interval | baseline, day 1, day 7 | — |
| Change in RR interval | baseline, day 1, day 7 | — |
| Change in heart rate (HR) | baseline, day 1, day 7 | — |
| Occurrence of ECG abnormalities | baseline, day 1, day 7 | — |
| Change in QT interval | baseline, day 1, day 7 | — |
| Change in U wave morphology | baseline, day 1, day 7 | normal, abnormal |
| Area under the plasma concentration time curve (AUC) | day 1, day 7 | — |
| Maximum plasma concentration (Cmax) | day 1, day 7 | — |
| Time to attain maximum plasma concentration (tmax) | day 1, day 7 | — |
| Trough plasma concentration at steady state (Cmin,ss) | day 7 | — |
| Number of participants with adverse events | up to 8 days after last treatment | — |
| Change in T wave morphology | baseline, day 1, day 7 | normal, flat, inverted, biphasic |
Outcome results
None listed