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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Hydrochlorothiazide; Telmisartan

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