Healthy
Conditions
Brief summary
A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
Interventions
DRUGHydrochlorothiazide
DRUGTelmisartan
DRUGTelmisartan/HCTZ FDC
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞) | Pre-dose up to day 54 |
| Maximum concentration of the analytes in plasma (Cmax) | Pre-dose up to day 54 |
| Amount of HCTZ excreted in urine over 48 h (Ae(0-48)) | Pre-dose up to day 50 |
Secondary
| Measure | Time frame |
|---|---|
| Total mean residence time of the analytes (MRTtot) | Pre-dose up to day 54 |
| Apparent volume of distribution of the analytes during the terminal phase (Vz/f) | Pre-dose up to day 54 |
| Number of patients with relevant changes in laboratory values | Screening (day -14 to day 0) and day 72 |
| time to achieve maximum concentration of the analytes in plasma (tmax) | Pre-dose up to day 54 |
| Number of patients with Adverse events | Up to day 72 |
| Number of patients with relevant changes in ECG | Screening (day -14 to day 0) and day 72 |
| Number of patients with relevant changes in physical examination | Screening (day -14 to day 0) and day 72 |
| Number of patients with relevant changes in vital signs (blood pressure, pulse rate) | Up to day 72 |
| Terminal elimination half life of the analytes in plasma (t1/2) | Pre-dose up to day 54 |
| Total clearance of the of the analytes after oral administration (CLtot/f) | Pre-dose up to day 54 |
Outcome results
None listed