Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects

Launched by BOEHRINGER INGELHEIM · Jul 9, 2014

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Eligibility criteria

• Inclusion Criteria:
• • Healthy subjects as determined by results of screening
• • Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• • Age ≥ 18 and ≤ 55 years
• • Broca ≥ -20 % and ≤ +20 %
• Exclusion Criteria:
• • Any findings 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 the gastro-intestinal tract (except appendectomy)
• • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• • Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
• • History of orthostatic hypotension, fainting, spells or blackouts
• • Chronic or relevant acute infection
• • History or 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 (≤ 1 month prior to administration or during the trial)
• • Excessive physical activities (≤ 5 days prior to administration or during the trial)
• • Any laboratory value outside the reference range of clinical relevance
• • Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
• For female subjects:
• • Pregnancy
• • Positive pregnancy test
• • No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral contraceptives)
• • Inability to maintain this adequate contraception during the whole study period
• • Lactation period