Clinical trial NCT02176512: Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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 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

Primary outcomes:
measure: AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity)
timeFrame: up to 96 hours post-dose
measure: Cmax (maximum drug plasma concentration)
timeFrame: up to 96 hours post-dose
measure: Amount of Hydrochlorothiazide (HCTZ) excreted in urine over 48 hours (Ae(0-48h))
timeFrame: 0-6, 6-12, 12-24, 24-32, 32-48 hours post-dose
Secondary outcomes:
measure: tmax (time to achieve Cmax)
timeFrame: up to 96 hours post-dose
measure: t1/2 (apparent terminal elimination half-life)
timeFrame: up to 96 hours post-dose
measure: CLtot/f (total clearance of a drug from plasma, divided by bioavailability)
timeFrame: up to 96 hours post-dose
measure: MRTtot (mean time of residence of drug molecules in the body)
timeFrame: up to 96 hours post-dose
measure: Vz/f (apparent volume of distribution during terminal phase)
timeFrame: up to 96 hours post-dose
measure: Number of patients with adverse events
timeFrame: Up to 62 days
Other outcomes:
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