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Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use

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ClinicalTrials.gov Identifier: NCT02121535
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 22, 2014
First Posted Date  ICMJE April 23, 2014
Results First Submitted Date  ICMJE October 6, 2016
Results First Posted Date  ICMJE April 12, 2017
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration ]
    Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
  • Cmax for Telmisartan [ Time Frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration ]
    Cmax (maximum measured concentration of the analyte in plasma)
  • AUC0-tz for Amlodipine [ Time Frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration ]
    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)
  • Cmax for Amlodipine [ Time Frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration ]
    Cmax (maximum measured concentration of the analyte in plasma)
  • Cmax for Hydrochlorothiazide [ Time Frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration ]
    Cmax (maximum measured concentration of the analyte in plasma)
  • AUC0-tz for Hydrochlorothiazide [ Time Frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration ]
    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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • Maximum measured concentration (Cmax) of the analyte in plasma [ Time Frame: 2 months ]
  • Area under the concentration-time curve (AUC 0-tz) of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration [ Time Frame: 2 months ]
Change History Complete list of historical versions of study NCT02121535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • AUC0-∞ for Telmisartan [ Time Frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration ]
    AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
  • AUC0-∞ for Amlodipine [ Time Frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration ]
    AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
  • AUC0-∞ for Hydrochlorothiazide [ Time Frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration ]
    AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
Area under the concentration-time curve (AUC 0-infinity) of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
Official Title  ICMJE Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Hydrochlorothiazide 12.5 mg Tablet in Healthy Male Subjects : an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study
Brief Summary The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.
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: T80/A5 mg FDC tablet
  • Drug: T80/A5 mg FDC tablet
    A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet
  • Drug: H12.5 mg tablet
  • Drug: T80/A5/H12.5 ng FDC tablet
    A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet
  • Drug: H12.5 mf tablet
    A HCTZ 12.5 mg tablet
  • Drug: T80/A5/H12.5 mg FDC tablet
Study Arms  ICMJE
  • Experimental: T80/A5/H12.5 mg FDC
    A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet
    Interventions:
    • Drug: T80/A5 mg FDC tablet
    • Drug: H12.5 mg tablet
    • Drug: T80/A5/H12.5 mg FDC tablet
  • Active Comparator: T80/A5 mg FDC+H12.5 mg mono
    A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet
    Interventions:
    • Drug: T80/A5 mg FDC tablet
    • Drug: T80/A5/H12.5 ng FDC tablet
    • Drug: H12.5 mf tablet
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: April 22, 2014)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Healthy male subjects age =20 and =35 years; body weight: =50 kg and =80 kg; body mass index: =18.0 and =25.0 kg/m2
  • Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
  • Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.

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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02121535
Other Study ID Numbers  ICMJE 1348.3
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
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2017

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