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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Hydrochlorothiazide

Drug: Telmisartan/HCTZ FDC

Drug: Telmisartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02187523

502.324

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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