Healthy
Conditions
Brief summary
Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
Interventions
DRUGBIBR 277 SE and HCTZ
Treatment A - fixed dose combination
DRUGBIBR 277 SE
Treatment B - Monocomponent
DRUGHCTZ
Treatment B -Monocomponent
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects as determined by results of screening * Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation * Age ≥ 18 and ≤ 45 years * Broca ≥ - 20% and ≤ + 20%
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: * Pregnancy * Positive pregnancy test * No adequate contraception * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity) | up to 96 hours post-dose |
| Cmax (maximum drug plasma concentration) | up to 96 hours post-dose |
| Amount of Hydrochlorothiazide (HCTZ) excreted in urine over 48 hours (Ae(0-48h)) | 0-6, 6-12, 12-24, 24-32, 32-48 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| MRTtot (mean time of residence of drug molecules in the body) | up to 96 hours post-dose |
| tmax (time to achieve Cmax) | up to 96 hours post-dose |
| Number of patients with adverse events | Up to 62 days |
| Vz/f (apparent volume of distribution during terminal phase) | up to 96 hours post-dose |
| t1/2 (apparent terminal elimination half-life) | up to 96 hours post-dose |
| CLtot/f (total clearance of a drug from plasma, divided by bioavailability) | up to 96 hours post-dose |
Outcome results
None listed