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Trial record 52 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02276378
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: Telmisartan low Drug: Telmisartan high Drug: Hydrochlorothiazide (HCTZ) Other: Japanese meal 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: Influence of Food on the Bioavailability of Telmisartan 40 mg/HCTZ 12.5 mg Fixed-dose Combination and of Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination in Japanese Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study Start Date : July 2008
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan low / HCTZ fixed-dose combination, fed Drug: Telmisartan low
Drug: Hydrochlorothiazide (HCTZ)
Other: Japanese meal
Experimental: Telmisartan high / HCTZ fixed-dose combination, fed Drug: Telmisartan high
Drug: Hydrochlorothiazide (HCTZ)
Other: Japanese meal
Active Comparator: Telmisartan low /HCTZ fixed-dose combination, fasted Drug: Telmisartan low
Drug: Hydrochlorothiazide (HCTZ)
Active Comparator: Telmisartan high /HCTZ fixed-dose combination, fasted Drug: Telmisartan high
Drug: Hydrochlorothiazide (HCTZ)



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

Secondary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: Up to 72 hours after drug administration ]
  2. Time from dosing to the maximum concentration of the analyte in the plasma (tmax) [ Time Frame: Up to 72 hours after drug administration ]
  3. Terminal rate constant in the plasma (λz) [ Time Frame: Up to 72 hours after drug administration ]
  4. Terminal half-life of the analyte in the plasma (t1/2) [ Time Frame: Up to 72 hours after drug administration ]
  5. Mean residence time of the analyte in the body after oral administration (MRTpo) [ Time Frame: Up to 72 hours after drug administration ]
  6. Number of participants with abnormal findings in physical examination [ Time Frame: Up to 72 hours after drug administration ]
  7. Number of participants with clinically significant findings in vital signs [ Time Frame: Up to 72 hours after last drug administration ]
  8. Number of participants with clinically significant findings in 12-lead ECG [ Time Frame: Up to 72 hours after drug administration ]
  9. Number of participants with clinically significant findings in clinical laboratory parameters [ Time Frame: Up to 72 hours after drug administration ]
  10. Number of participants with adverse events [ Time Frame: Up to 7 days after drug administration ]


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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:

Healthy males according to the following criteria:

  1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
  2. Age ≥20 and Age ≤35 years
  3. Body weight ≥50 kg
  4. BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
  5. Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  3. Chronic or relevant acute infections
  4. Any clinical relevant findings of the laboratory test deviating from normal
  5. Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
  6. History of surgery of gastrointestinal tract (except appendectomy)
  7. History of relevant orthostatic hypotension, fainting spells or blackouts
  8. Known hypersensitivity to any component of the formulation (telmisartan and hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
  9. 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
  10. 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
  11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
  12. Smoker (≥20 cigarettes/day)
  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 4 weeks prior to administration or during the trial)
  16. Excessive physical activities (within 1 week prior to administration or during the trial)
  17. Intake of alcohol within 2 days prior to administration
  18. Inability to comply with dietary regimen of study centre
  19. Inability to refrain from smoking on trial days
  20. Subjects judged to be inappropriate by the investigator or the sub-investigator

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02276378     History of Changes
Other Study ID Numbers: 502.569
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 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