Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Lacidipine; Telmisartan

Criteria

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 exclusion criteria are of special interest for this study:

• Hypersensitivity to telmisartan, lacidipine and/or related drugs of these classes

• Supine blood pressure at screening of systolic <= 110 mmHg and diastolic <= 60 mmHg

• Any ECG value outside of the reference range of clinical relevance, but not limited to PR interval > 240 ms, QRS interval > 110 ms, QTcB > 470 ms for females and QTcB > 450 ms for males

For female subjects:

• Pregnancy

• Positive pregnancy test

• No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pessary (IUP), oral contraceptives)

• Inability to maintain this adequate contraception during the whole study period

• Lactation period