HealthyPhase 1NCT02259803
Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers
A Phase 1 study testing Telmisartan/amlodipine fixed-dose combination (FDC) tablet, Telmisartan and Amlodipine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the relative bioavailability of fixed-dose combination tablet vs. mono-components of telmisartan and amlodipine 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 fixed-dose combination (FDC) tablet, Telmisartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Nov 2007
- 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 males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice
Who cannot join
- 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 hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test
- Surgery of gastrointestinal tract (except appendectomy)
Show all 26Show fewer
- 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 formulation, or to any other angiotensin II receptor blockers, angiotensin converting enzyme or dihydropyridine
- 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
- Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration
- Inability to refrain from smoking on trial days
- Any other volunteers whom, the principal investigator or sub investigator would not allow to participate in this study
About this study
Official title: Relative Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet Compared to Concomitant Use of Its Mono-components (i.e., Two Telmisartan 40 mg Tablets and Amlodipine 5 mg Tablet in Concomitant Use) Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
Study to investigate the relative bioavailability of fixed-dose combination tablet vs.
mono-components of telmisartan and amlodipine
- Conditions
- Healthy
- Being tested
- Telmisartan/amlodipine fixed-dose combination (FDC) tablet, Telmisartan, Amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/amlodipine fixed-dose combination (FDC) tabletDrug
TelmisartanDrug
AmlodipineDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan/amlodipine fixed-dose combination | Experimental | Not described Receives: Drug: Telmisartan/amlodipine fixed-dose combination (FDC) tablet |
| Telmisartan and amlodipine mono-components | Active comparator | Not described Receives: Drug: Telmisartan; Drug: Amlodipine |
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 last quantifiable data point (AUC0-tz)
Measured: up to 144 hours after administration of study drug
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 144 hours after administration of study drug
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 administration of study drug
Time from administration to the maximum concentration of the analyte in plasma (tmax)
Measured: up to 144 hours after administration of study drug
Terminal rate constant of the analyte in plasma (λz)
Measured: up to 144 hours after administration of study drug
Terminal rate constant of the analyte in plasma (t1/2)
Measured: up to 144 hours after administration of study drug
Mean residence time of the analyte in the body after po administration (MRTpo)
Measured: up to 144 hours after administration of study drug
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 posted9 Oct 2014 (estimated)
- Study startOct 2007
- Primary completionNov 2007
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
- 30 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
- NCT02259803
- Sponsor's protocol ID
- 1235.18
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet Compared to Concomitant Use of Its Mono-components (i.e., Two Telmisartan 40 mg Tablets and Amlodipine 5 mg Tablet in Concomitant Use) Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02259803
- Acronym / sponsor ID
- 1235.18
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- First posted
- 9 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 of fixed-dose combination tablet vs.
mono-components of telmisartan and amlodipine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan/amlodipine fixed-dose combination | Experimental | Drug: Telmisartan/amlodipine fixed-dose combination (FDC) tablet |
| Telmisartan and amlodipine mono-components | Active comparator | Drug: Telmisartan, Drug: Amlodipine |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)
Key exclusion criteria (26 listed)
- 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 hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or 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 fixed-dose combination (FDC) tablet | Drug | Telmisartan/amlodipine fixed-dose combination |
| Telmisartan | Drug | Telmisartan and amlodipine mono-components |
| Amlodipine | Drug | Telmisartan and amlodipine mono-components |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 144 hours after administration of study drug
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 144 hours after administration of study drug
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 administration of study drug
Time from administration to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 144 hours after administration of study drug
Terminal rate constant of the analyte in plasma (λz)
Time frame: up to 144 hours after administration of study drug
Terminal rate constant of the analyte in plasma (t1/2)
Time frame: up to 144 hours after administration of study drug
Mean residence time of the analyte in the body after po administration (MRTpo)
Time frame: up to 144 hours after administration of study drug
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 9 Oct 2014.
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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 fixed-dose combination (FDC) tablet, Telmisartan and Amlodipine 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 6 inclusion and 26 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 9 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 last quantifiable data point (AUC0-tz) (time frame: up to 144 hours after administration of study drug). 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 9 Oct 2014.