Relative Oral Bioavailability of 80 mg Telmisartan / 12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Subjects. A 4 Period Cross-over, Open, Randomized, Replicate Design Study.
Relative Oral Bioavailability of 80 mg Telmisartan / 12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Subjects. A 4 Period Cross-over, Open, Randomized, Replicate Design Study.
Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
Inclusion Criteria:
Exclusion Criteria:
Any findings of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) 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
Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
History of orthostatic hypotension, fainting spells or blackouts
Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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
Known alcohol abuse
Known drug abuse
Blood donation (≤ 1 month prior to administration)
Excessive physical activities (≤ 5 days prior to administration)
For female subjects: