- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02259777
Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Male and Female Volunteers
October 6, 2014 updated by: Boehringer Ingelheim
Influence of Food on the Bioavailability of 80 mg Telmisartan/10 mg Amlodipine Fixed Dose Combination in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Period, Crossover Study
Study to investigate the effect of food intake on the bioavailability of a fixed dose combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- 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 except for oral contraceptives as well as ovary and thyroid hormone replacement
- Use of drugs which might reasonably influence the results of the trial (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/corrected QT interval 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 one month prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking during 24 hours prior to dosing and during the trial
- Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
- 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 is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Any history of relevant low blood pressure
- Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg
- History of urticaria
- History of angioneurotic edema
Fructose intolerance
For female subjects:
- Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
- No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, IUD [intrauterine device], sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
- Lactation period
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/Amlodipine, fed
|
Fixed dose combination tablet
|
Active Comparator: Telmisartan/Amlodipine, fasted
|
Fixed dose combination tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity (AUC0-∞)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with adverse events
Time Frame: up to 65 days
|
up to 65 days
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: day 8 after administration of study drug
|
day 8 after administration of study drug
|
Area under the concentration-time curve of telmisartan and amlodipine in plasma over the time interval zero to the last quantifiable data point (AUC0-tz)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Time from dosing to the maximum concentration in plasma (tmax)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Terminal rate constant in plasma (λz)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Terminal half-life in plasma (t1/2)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Mean residence time in the body after po administration (MRTpo)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Apparent plasma clearance after p.o. administration (CL/F)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Apparent volume of distribution during the terminal phase λz after p.o. administration (Vz/F)
Time Frame: up to 168 hours after drug administration
|
up to 168 hours after 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
September 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
October 6, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (Estimate)
October 9, 2014
Study Record Updates
Last Update Posted (Estimate)
October 9, 2014
Last Update Submitted That Met QC Criteria
October 6, 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
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Telmisartan
- Telmisartan amlodipine combination
Other Study ID Numbers
- 1235.12
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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