Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan; Drug: Placebo; Drug: Lacidipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02218684

1173.1

Details and patient eligibility

About

The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 4 patient groups, including a placebo group

Telmisartan + Lacidipine - low dose

Experimental group

Treatment:

Drug: Lacidipine

Drug: Telmisartan

Telmisartan + Lacidipine - medium dose

Experimental group

Treatment:

Drug: Lacidipine

Drug: Telmisartan

Telmisartan + Lacidipine - high dose

Experimental group

Treatment:

Drug: Lacidipine

Drug: Telmisartan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo