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

Overview

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

Full Title of Study: “Relative Oral Bioavailability of 40 mg Telmisartan / 12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Subjects. A 4 Period Cross-over, Open, Randomized, Replicate Design Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1999

Interventions

  • Drug: Hydrochlorothiazide
  • Drug: Telmisartan
  • Drug: Telmisartan/HCTZ FDC

Arms, Groups and Cohorts

  • Experimental: Telmisartan/HCTZ FDC
  • Active Comparator: Telmisartan and HCTZ individual tablets

Clinical Trial Outcome Measures

Primary Measures

  • Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
    • Time Frame: Pre-dose up to day 54
  • Maximum concentration of the analytes in plasma (Cmax)
    • Time Frame: Pre-dose up to day 54
  • Amount of HCTZ excreted in urine over 48 h (Ae(0-48))
    • Time Frame: Pre-dose up to day 50

Secondary Measures

  • time to achieve maximum concentration of the analytes in plasma (tmax)
    • Time Frame: Pre-dose up to day 54
  • Terminal elimination half life of the analytes in plasma (t1/2)
    • Time Frame: Pre-dose up to day 54
  • Total clearance of the of the analytes after oral administration (CLtot/f)
    • Time Frame: Pre-dose up to day 54
  • Total mean residence time of the analytes (MRTtot)
    • Time Frame: Pre-dose up to day 54
  • Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
    • Time Frame: Pre-dose up to day 54
  • Number of patients with relevant changes in laboratory values
    • Time Frame: Screening (day -14 to day 0) and day 72
  • Number of patients with relevant changes in vital signs (blood pressure, pulse rate)
    • Time Frame: Up to day 72
  • Number of patients with Adverse events
    • Time Frame: Up to day 72
  • Number of patients with relevant changes in ECG
    • Time Frame: Screening (day -14 to day 0) and day 72
  • Number of patients with relevant changes in physical examination
    • Time Frame: Screening (day -14 to day 0) and day 72

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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