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

October 10, 2014 updated by: Boehringer Ingelheim

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan and HCTZ (fix dose combination)
Active Comparator: Telmisartan and HCTZ (monocomponent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: up to 72 hours after drug administration
up to 72 hours after drug administration
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
up to 72 hours after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 72 hours after drug administration
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
up to 72 hours after drug administration
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
up to 72 hours after drug administration
Number of subjects with adverse events
Time Frame: up to 7 days after last drug administration
up to 7 days after last drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time Frame: up to 72 hours after drug administration
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
up to 72 hours after drug administration
Number of subjects with clinically significant changes in vital signs
Time Frame: up to 7 days after last drug administration
blood pressure, pulse rate
up to 7 days after last drug administration
Number of subjects with clinically significant changes in 12 lead ECG
Time Frame: up to 7 days after last drug administration
up to 7 days after last drug administration
Number of subjects with clinically significant changes in laboratory tests
Time Frame: up to 7 days after last drug administration
up to 7 days after last drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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