- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263989
Bioequivalence of Telmisartan Film-coated Tablet Compared With the Conventional Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers
October 13, 2014 updated by: Boehringer Ingelheim
Bioequivalence of the 40 mg Telmisartan Film-coated Tablet Compared With the Conventional 40 mg Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study)
Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the conventional 40 mg telmisartan tablet
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
- No findings deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥17.6 and ≤26.4 kg/m2
- 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:
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B surface antigen (HBs antigen), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
- History of surgery of gastrointestinal tract (except appendectomy)
- History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
- History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)
- History of serious renal dysfunction
- History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- History of cerebrovascular disorder
- History of hyperkalemia
- Known hypersensitivity to any component of the telmisartan formulation, or to any other angiotensin II receptor blockers (ARBs)
- 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
- 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
- Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
- Smoker (≥20 cigarettes/day)
- Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to administration or during the trial)
- Intake of alcohol within 2 days prior to administration
- Inability to comply with dietary regimen of study centre
- Inability to refrain from smoking on trial days
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 film coated tablet
|
|
Active Comparator: Telmisartan conventional tablet
|
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 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 |
---|---|---|
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
|
|
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
|
|
tmax (time from dosing to the maximum measured concentration 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 adverse events
Time Frame: up to 72 hours after last administration
|
up to 72 hours after last administration
|
|
Number of subjects with clinically significant findings in vital signs
Time Frame: up to 72 hours after last administration
|
blood pressure, pulse rate, body temperature
|
up to 72 hours after last administration
|
Number of subjects with clinically significant findings in 12-lead electrocardiogram
Time Frame: up to 72 hours after last administration
|
up to 72 hours after last administration
|
|
Number of subjects with clinically significant findings in laboratory tests
Time Frame: up to 72 hours after last administration
|
up to 72 hours after last administration
|
|
Number of subjects with clinically significant findings in physical examination
Time Frame: up to 72 hours after last administration
|
up to 72 hours after last administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2007
Primary Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
October 13, 2014
First Submitted That Met QC Criteria
October 13, 2014
First Posted (Estimate)
October 15, 2014
Study Record Updates
Last Update Posted (Estimate)
October 15, 2014
Last Update Submitted That Met QC Criteria
October 13, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502.520
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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