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Trial record 35 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

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ClinicalTrials.gov Identifier: NCT02187523
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Hydrochlorothiazide Drug: Telmisartan Drug: Telmisartan/HCTZ FDC Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : October 1999
Actual Primary Completion Date : December 1999

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan/HCTZ FDC Drug: Telmisartan/HCTZ FDC
Active Comparator: Telmisartan and HCTZ individual tablets Drug: Hydrochlorothiazide
Drug: Telmisartan



Primary Outcome Measures :
  1. 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 ]
  2. Maximum concentration of the analytes in plasma (Cmax) [ Time Frame: Pre-dose up to day 54 ]
  3. Amount of HCTZ excreted in urine over 48 h (Ae(0-48)) [ Time Frame: Pre-dose up to day 50 ]

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


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02187523    
Other Study ID Numbers: 502.324
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists