Clinical trial NCT02187523: Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects
Official title: Relative Oral Bioavailability of 40 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations


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

Primary outcomes:
measure: Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
timeFrame: Pre-dose up to day 54
measure: Maximum concentration of the analytes in plasma (Cmax)
timeFrame: Pre-dose up to day 54
measure: Amount of HCTZ excreted in urine over 48 h (Ae(0-48))
timeFrame: Pre-dose up to day 50
Secondary outcomes:
measure: time to achieve maximum concentration of the analytes in plasma (tmax)
timeFrame: Pre-dose up to day 54
measure: Terminal elimination half life of the analytes in plasma (t1/2)
timeFrame: Pre-dose up to day 54
measure: Total clearance of the of the analytes after oral administration (CLtot/f)
timeFrame: Pre-dose up to day 54
measure: Total mean residence time of the analytes (MRTtot)
timeFrame: Pre-dose up to day 54
measure: Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
timeFrame: Pre-dose up to day 54
measure: Number of patients with relevant changes in laboratory values
timeFrame: Screening (day -14 to day 0) and day 72
measure: Number of patients with relevant changes in vital signs (blood pressure, pulse rate)
timeFrame: Up to day 72
measure: Number of patients with Adverse events
timeFrame: Up to day 72
measure: Number of patients with relevant changes in ECG
timeFrame: Screening (day -14 to day 0) and day 72
measure: Number of patients with relevant changes in physical examination
timeFrame: Screening (day -14 to day 0) and day 72
Other outcomes:
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