Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Telmisartan and HCTZ individual tablets	Hydrochlorothiazide	-
Telmisartan/HCTZ FDC	Telmisartan/HCTZ FDC	-
Telmisartan and HCTZ individual tablets	Telmisartan	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
time to achieve maximum concentration of the analytes in plasma (tmax)	Pre-dose up to day 54
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
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
Number of patients with relevant changes in vital signs (blood pressure, pulse rate)	Up to day 72
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

Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects

Recruitment & Eligibility

Study & Design

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