Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects

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

Summary

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 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