Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Bioequivalence of Telmisartan as Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets in Healthy Male Volunteers

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: NCT02276391
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 establish bioequivalence of telmisartan orally administrated in two different ways: either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or with two telmisartan 40 mg tablets

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of Telmisartan Administrated in Two Different Ways: Either in Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)
Study Start Date : July 2008
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan/HCTZ fixed-dose combination Drug: Telmisartan/HCTZ combination
Active Comparator: Telmisartan Drug: Telmisartan



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 time of 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 measured 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 participants with clinically significant findings in physical examination [ Time Frame: Up to 72 hours after last 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 (electrocardiogram) [ Time Frame: Up to 72 hours after last drug administration ]
  9. Number of participants with clinically significant findings in clinical laboratory parameters [ Time Frame: Up to 72 hours after last drug administration ]
  10. Number of participants with adverse events [ Time Frame: Up to 72 hours after last drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Healthy Japanese 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. Body Mass Index (BMI) ≥18.0 and BMI ≤25.0 kg/m2
  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. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)
  10. History of serious renal dysfunction
  11. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
  12. History of cerebrovascular disorder
  13. History of hyperkalemia
  14. History of impaired glucose tolerance
  15. History of hypokalemia
  16. History of hyperuricemia
  17. Salt restriction therapy
  18. 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
  19. 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
  20. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
  21. Smoker (≥20 cigarettes /day))
  22. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
  23. Drug abuse
  24. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
  25. Excessive physical activities (within 1 week prior to administration or during the trial)
  26. Intake of alcohol within 2 days prior to administration
  27. Inability to comply with dietary regimen of study centre
  28. Inability to refrain from smoking on trial days
  29. Subjects judged to be inappropriate by the investigator or the sub-investigator

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02276391     History of Changes
Other Study ID Numbers: 502.571
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action