HealthyPhase 1NCT02261064
Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers
A Phase 1 study testing Telmisartan/Amlodipine low dose, Telmisartan/Amlodipine high dose and Japanese meal in people with Healthy, run by Boehringer Ingelheim.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan/Amlodipine low dose, Telmisartan/Amlodipine high dose and Japanese meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Telmisartan/Amlodipine low dose, Telmisartan/Amlodipine high dose, Japanese meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/Amlodipine low doseDrug
Telmisartan/Amlodipine high doseDrug
Japanese mealOther
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan/Amlodipine low dose, fed | Experimental | Telmisartan low dose/Amlodipine fixed-dose combination Receives: Drug: Telmisartan/Amlodipine low dose; Other: Japanese meal |
| Telmisartan/Amlodipine low dose, fasted | Active comparator | Telmisartan low dose/Amlodipine fixed-dose combination Receives: Drug: Telmisartan/Amlodipine low dose |
| Telmisartan/Amlodipine high dose, fed | Experimental | Telmisartan high dose/Amlodipine fixed-dose combination Receives: Drug: Telmisartan/Amlodipine high dose; Other: Japanese meal |
| Telmisartan/Amlodipine high dose, fasted | Active comparator | Telmisartan high dose/Amlodipine fixed-dose combination Receives: Drug: Telmisartan/Amlodipine high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 144 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 144 hours after drug administration
Secondary outcomes (6)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 144 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: up to 144 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Measured: up to 144 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 144 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Measured: up to 144 hours after drug administration
Number of subjects with adverse events
Measured: up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startDec 2008
- Primary completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261064
- Sponsor's protocol ID
- 1235.27
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02261064
- Acronym / sponsor ID
- 1235.27
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telmisartan/Amlodipine low dose, fed | Experimental | Drug: Telmisartan/Amlodipine low dose, Other: Japanese mealTelmisartan low dose/Amlodipine fixed-dose combination |
| Telmisartan/Amlodipine low dose, fasted | Active comparator | Drug: Telmisartan/Amlodipine low doseTelmisartan low dose/Amlodipine fixed-dose combination |
| Telmisartan/Amlodipine high dose, fed | Experimental | Drug: Telmisartan/Amlodipine high dose, Other: Japanese mealTelmisartan high dose/Amlodipine fixed-dose combination |
| Telmisartan/Amlodipine high dose, fasted | Active comparator | Drug: Telmisartan/Amlodipine high doseTelmisartan high dose/Amlodipine fixed-dose combination |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan/Amlodipine low dose | Drug | Telmisartan/Amlodipine low dose, fasted, Telmisartan/Amlodipine low dose, fed |
| Telmisartan/Amlodipine high dose | Drug | Telmisartan/Amlodipine high dose, fasted, Telmisartan/Amlodipine high dose, fed |
| Japanese meal | Other | Telmisartan/Amlodipine high dose, fed, Telmisartan/Amlodipine low dose, fed |
Primary outcome
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
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 144 hours after drug administration
6 secondary outcomes
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
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: 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
Terminal half-life of the analyte in plasma (t1/2)
Time frame: 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
Number of subjects with adverse events
Time frame: up to 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telmisartan/Amlodipine low dose, Telmisartan/Amlodipine high dose and Japanese meal in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.