Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lacidipine; Drug: Telmisartan; Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209649

1173.6

Details and patient eligibility

About

Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.

Enrollment: 12 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
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20 % and ≤ + 20 %
• Written informed consent in accordance with Good Clinical Practice and local legislation given

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Surgery of gastrointestinal tract (except appendectomy)

• Disease 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, except for oral contraceptives)

• Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)

• 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 trial days

• Alcohol abuse (> 60 g/day)

• 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

• Females only:

  • no reliable contraception (e.g. oral contraceptives, 3-month injection, intrauterine device, sterilisation)
  • pregnancy of breast feeding period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Telmisartan and Lacidipine FDC, formulation A

Experimental group

Treatment:

Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet

Telmisartan and Lacidipine FDC, formulation B

Experimental group

Treatment:

Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet

Lacidipine and Telmisartan, mono

Active Comparator group

Treatment:

Drug: Lacidipine

Drug: Telmisartan