Safety, Tolerability and Pharmacokinetics of Single Rising and Multiple Oral Doses of Telmisartan / Hydrochlorothiazide (HCTZ) in Healthy Male Volunteers

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

Summary

Group 1:

To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5)

Group 2:

To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)

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

Details

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

Criteria

Inclusion Criteria:

• Healthy males according to the following criteria: No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory tests

• Age ≥20 and Age ≤35 years

• Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2

• Signed and dated written informed consent prior to admission to the study in accordance with "Good Clinical Practice (GCP)"

Exclusion Criteria:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

• Chronic or relevant acute infections

• Any laboratory value outside the reference range that is of clinical relevance

• Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV) antibodies, Syphilitic test or HIV test

• Surgery of gastrointestinal tract (except appendectomy)

• History of relevant orthostatic hypotension (mean standing SBP varies by ≥ 20 mmHg from mean supine systolic blood pressure (SBP) and/or mean standing diastolic blood pressure (DBP) varies by ≥ 10 mmHg from mean supine DBP), fainting spells or blackouts.

• History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)

• History of serious renal dysfunction

• History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney

• History of cerebrovascular disorder

• History of hyperkalemia

• Known hypersensitivity to any component of the formulation; known hypersensitivity to any other angiotensin II receptor antagonist; known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides)

• History of impaired glucose tolerance

• History of hypokalemia

• History of hyperuricemia

• Salt restriction therapy

• Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial

• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial

• Participation in another trial with an investigational drug within four months or 6 half-lives of the investigational drug, whichever is longer, prior to administration or during the trial

• Smoker (more than 20 cigarettes /day)

• Alcohol abuse

• Drug abuse

• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

• Excessive physical activities (within seven days prior to administration)

• Intake of alcohol within two days prior to administration

• Inability to comply with dietary regimen of study centre

• Inability to comply with smoking cessation during hospitalization