Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan; Drug: Lacidipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02203500

1173.2

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Lacidipine

Experimental group

Treatment:

Drug: Lacidipine

Telmisartan

Experimental group

Treatment:

Drug: Telmisartan

Lacidipine + Telmisartan

Experimental group

Treatment:

Drug: Lacidipine

Drug: Telmisartan