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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

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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

Tracking Information
First Submitted Date  ICMJE October 27, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date October 28, 2014
Study Start Date  ICMJE July 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • 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 ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • 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 ]
  • tmax (time from dosing to the maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  • λz (terminal rate constant of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Up to 72 hours after drug administration ]
  • MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: Up to 72 hours after drug administration ]
  • Number of participants with clinically significant findings in physical examination [ Time Frame: Up to 72 hours after last drug administration ]
  • Number of participants with clinically significant findings in vital signs [ Time Frame: Up to 72 hours after last drug administration ]
  • Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram) [ Time Frame: Up to 72 hours after last drug administration ]
  • Number of participants with clinically significant findings in clinical laboratory parameters [ Time Frame: Up to 72 hours after last drug administration ]
  • Number of participants with adverse events [ Time Frame: Up to 72 hours after last drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Telmisartan/HCTZ combination
  • Drug: Telmisartan
Study Arms  ICMJE
  • Experimental: Telmisartan/HCTZ fixed-dose combination
    Intervention: Drug: Telmisartan/HCTZ combination
  • Active Comparator: Telmisartan
    Intervention: Drug: Telmisartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2014)
64
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276391
Other Study ID Numbers  ICMJE 502.571
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP