HealthyPhase 1NCT02193308
Bioequivalence of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers
A Phase 1 study testing Telmisartan/Amlodipine FDC, Telmisartan and Amlodipine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination (FDC) vs. its monocomponents Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan/Amlodipine FDC, Telmisartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Sep 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 ≤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
Who cannot join
- 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
Show all 28Show fewer
- 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
- 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/QTc 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 two months 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
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)
- 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
- 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, 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
About this study
Official title: Bioequivalence of 80 mg Telmisartan / 10 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Sequence, Two-period Crossover Study
To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination (FDC) vs. its monocomponents
- Conditions
- Healthy
- Being tested
- Telmisartan/Amlodipine FDC, Telmisartan, Amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/Amlodipine FDCDrug
TelmisartanDrug
AmlodipineDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan/Amlodipine FDC | Experimental | Not described Receives: Drug: Telmisartan/Amlodipine FDC |
| Telmisartan + Amlodipine mono | 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.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 168 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 168 hours after drug administration
Secondary outcomes (9)
AUC0-tz (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)
Measured: up to 168 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 168 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 168 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 168 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 168 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after oral administration)
Measured: up to 168 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz after oral administration)
Measured: up to 168 hours after drug administration
Number of patients with adverse events
Measured: up to 65 days
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 8 of each trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startSep 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
- 84 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
- NCT02193308
- Sponsor's protocol ID
- 1235.4
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of 80 mg Telmisartan / 10 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Sequence, Two-period Crossover Study
- ClinicalTrials.gov ID
- NCT02193308
- Acronym / sponsor ID
- 1235.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- First posted
- 17 Jul 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.
To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination (FDC) vs. its monocomponents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan/Amlodipine FDC | Experimental | Drug: Telmisartan/Amlodipine FDC |
| Telmisartan + Amlodipine mono | Active comparator | Drug: Telmisartan, Drug: Amlodipine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 ≤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
Key exclusion criteria (28 listed)
- 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
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 FDC | Drug | Telmisartan/Amlodipine FDC |
| Telmisartan | Drug | Telmisartan + Amlodipine mono |
| Amlodipine | Drug | Telmisartan + Amlodipine mono |
Primary outcome
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 168 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 168 hours after drug administration
9 secondary outcomes
AUC0-tz (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)
Time frame: up to 168 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 168 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 168 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 168 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 168 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after oral administration)
Time frame: up to 168 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz after oral administration)
Time frame: up to 168 hours after drug administration
Number of patients with adverse events
Time frame: up to 65 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 8 of each trial period
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 18 Jul 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 FDC, 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 5 inclusion and 28 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 18 Jul 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?
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 168 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 18 Jul 2014.