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Trial record 47 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262858
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide (HCTZ) fixed dose combination compared with its monocomponents

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of 80 mg Telmisartan/12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study)
Study Start Date : August 2005
Actual Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan and HCTZ (fix dose combination) Drug: Telmisartan and HCTZ
Active Comparator: Telmisartan and HCTZ (monocomponent) Drug: Telmisartan
Drug: HCTZ



Primary Outcome Measures :
  1. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: up to 72 hours after drug administration ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]

Secondary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours after drug administration ]
  2. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  3. λz (terminal rate constant of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  4. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  5. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: up to 72 hours after drug administration ]
  6. Number of subjects with adverse events [ Time Frame: up to 7 days after last drug administration ]
  7. Number of subjects with clinically significant changes in vital signs [ Time Frame: up to 7 days after last drug administration ]
    blood pressure, pulse rate

  8. Number of subjects with clinically significant changes in 12 lead ECG [ Time Frame: up to 7 days after last drug administration ]
  9. Number of subjects with clinically significant changes in laboratory tests [ Time Frame: up to 7 days after last drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure, pulse rate), 12- lead ECG, clinical laboratory tests (including gastric acid (GA) test)

    • No finding of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  2. Age ≥ 20 years and Age ≤ 35 years
  3. Body weight ≥ 50 kg
  4. Body mass index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
  5. Signed and dated written informed consent prior to admission to the study

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Surgery of gastrointestinal tract (except appendectomy)
  3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  4. History of relevant orthostatic hypotension, fainting spells or blackouts
  5. Chronic or relevant acute infections
  6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
  7. Positive result for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV), syphilitic test or human immunodeficiency virus (HIV) antigen-antibody test
  8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs during the trial
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  10. Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
  11. Smoker (20 or more cigarettes/day)
  12. Inability to refrain from smoking during hospitalization
  13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
  14. Drug abuse
  15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  16. Excessive physical activities (within one week prior to administration or during the trial)
  17. Any laboratory value outside the reference range that was of clinical relevance
  18. Inability to comply with dietary regimen of study centre
  19. Any other volunteers whom the investigator or sub investigator did not allow to participate in this study

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02262858    
Other Study ID Numbers: 502.495
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators