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

Bioavailability of Lacidipine 4 mg and Telmisartan 40 mg Administered Orally as Two Experimental Fixed Dose Combination Tablets Relative to Separate Tablets. An Open Randomised Three-way Cross-over Steady State Trial in 6 Female and 6 Male Healthy Subjects

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

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