- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261064
Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers
October 9, 2014 updated by: Boehringer Ingelheim
Influence of Food on the Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination and of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination in Healthy Japanese Male Volunteers (a Phase I, Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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 male volunteers without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
- Age: ≥20 and Age ≤35 years
- Body weight: ≥50 kg
- Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2
- 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:
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings in laboratory test results deviating from normal
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test
- History of surgery of the gastrointestinal tract (except appendectomy)
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound
- Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration
- Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration
- Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration
- Smoker (≥20 cigarettes/day)
- Alcohol abuse (60 g or more ethanol/day: e.g., 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 before drug administration)
- Excessive physical activities (within 1 week before drug administration)
- Intake of alcohol within 2 days before drug administration
- Inability to comply with dietary regimen of the study centre
- Inability to refrain from smoking during trial days
- Subjects judged to be inappropriate by the investigator or a sub-investigator
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 low dose, fed
Telmisartan low dose/Amlodipine fixed-dose combination
|
|
Active Comparator: Telmisartan/Amlodipine low dose, fasted
Telmisartan low dose/Amlodipine fixed-dose combination
|
|
Experimental: Telmisartan/Amlodipine high dose, fed
Telmisartan high dose/Amlodipine fixed-dose combination
|
|
Active Comparator: Telmisartan/Amlodipine high dose, fasted
Telmisartan high dose/Amlodipine fixed-dose combination
|
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 0 to the time of the last quantifiable data point (AUC0-tz)
Time Frame: up to 144 hours after drug administration
|
up to 144 hours after drug administration
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: up to 144 hours after drug administration
|
up to 144 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with adverse events
Time Frame: up to 56 days
|
up to 56 days
|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: up to 144 hours after drug administration
|
up to 144 hours after drug administration
|
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time Frame: up to 144 hours after drug administration
|
up to 144 hours after drug administration
|
Terminal rate constant of the analyte in plasma (λz)
Time Frame: up to 144 hours after drug administration
|
up to 144 hours after drug administration
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: up to 144 hours after drug administration
|
up to 144 hours after drug administration
|
Mean residence time of the analyte in the body after po administration (MRTpo)
Time Frame: up to 144 hours after drug administration
|
up to 144 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
December 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
October 9, 2014
First Submitted That Met QC Criteria
October 9, 2014
First Posted (Estimate)
October 10, 2014
Study Record Updates
Last Update Posted (Estimate)
October 10, 2014
Last Update Submitted That Met QC Criteria
October 9, 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
- 1235.27
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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