- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02262858
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
Intervention / Treatment
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:
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
- Age ≥ 20 years and Age ≤ 35 years
- Body weight ≥ 50 kg
- Body mass index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
- Signed and dated written informed consent prior to admission to the study
Exclusion Criteria:
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
- Positive result for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV), syphilitic test or human immunodeficiency virus (HIV) antigen-antibody test
- 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
- 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
- Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
- Smoker (20 or more cigarettes/day)
- Inability to refrain from smoking during hospitalization
- 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 four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of study centre
- 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.
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
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
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
- Telmisartan
Other Study ID Numbers
- 502.495
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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