Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects
- Registration Number
- NCT02176512
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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%
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Any findings of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance
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Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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Surgery of the gastro-intestinal tract (except appendectomy)
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Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
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Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
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History of orthostatic hypotension, fainting spells or blackouts
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Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
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History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
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Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
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Smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day)
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Inability to refrain from smoking on study days
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Known alcohol abuse
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Known drug abuse
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Blood donation (≤ 1 month prior to administration)
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 BIBR 277 SE four treatment periods: 1. Treatment A 2. Treatment B 3. Treatment B 4. Treatment A Sequence 2 BIBR 277 SE four treatment periods: 1. Treatment B 2. Treatment A 3. Treatment A 4. Treatment B Sequence 1 BIBR 277 SE and HCTZ four treatment periods: 1. Treatment A 2. Treatment B 3. Treatment B 4. Treatment A Sequence 2 BIBR 277 SE and HCTZ four treatment periods: 1. Treatment B 2. Treatment A 3. Treatment A 4. Treatment B Sequence 1 HCTZ four treatment periods: 1. Treatment A 2. Treatment B 3. Treatment B 4. Treatment A Sequence 2 HCTZ four treatment periods: 1. Treatment B 2. Treatment A 3. Treatment A 4. Treatment B
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 MRTtot (mean time of residence of drug molecules in the body) up to 96 hours post-dose Vz/f (apparent volume of distribution during terminal phase) up to 96 hours post-dose Number of patients with adverse events Up to 62 days tmax (time to achieve Cmax) up to 96 hours post-dose