HealthyPhase 1NCT02259816
Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers
A Phase 1 study testing Telmisartan and Amlodipine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 2006
- 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 50 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 Age ≤50 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 30Show 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 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 two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- 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/or diastolic <60 mm Hg
- History of urticaria
- For female subjects:
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test
- No adequate contraception e.g. sterilisation, intrauterine device, have not been using a barrier method of contraception for at least 3 months prior to participation in the study
- Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception
- Partner is unwilling to use condoms
- Lactation period
About this study
Official title: Pharmacokinetics of Repeated Oral Doses of 80 mg Telmisartan (Micardis®) at Steady State Alone and in Combination With Repeated Oral Doses of Amlodipine 10 mg (Norvasc®) at Steady State. A Two-way Crossover, Open, Randomised Design Study
Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine
- Conditions
- Healthy
- Being tested
- Telmisartan, Amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Also called Micardis®
AmlodipineDrug
Also called Norvasc®
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Active comparator | Not described Receives: Drug: Telmisartan |
| Telmisartan and amlodipine | Experimental | 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 telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Measured: up to 15 days after first administration of study drug
Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: up to 15 days after first administration of study drug
Secondary outcomes (17)
AUCτ,ss for amlodipine
Measured: up to 15 days after first administration of study drug
Cmax,ss for amlodipine
Measured: up to 15 days after first administration of study drug
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 12 hours after first administration of study drug
Time from dosing to maximum measured concentration on plasma (tmax)
Measured: up to 12 hours after first administration of study drug
Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)
Measured: up to 12 hours after first administration of study drug
Pre-dose concentration of the analyte in plasma immediately before the administration of the next dose N (Cpre,N)
Measured: pre-dose on days 2-9
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Measured: up to 144 hours after last administration of study drug
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: up to 144 hours after last administration of study drug
Terminal rate constant in plasma at steady state (λz,ss)
Measured: up to 144 hours after last administration of study drug
Terminal half-life of the analyte in plasma at steady state (t1/2, ss)
Measured: up to 144 hours after last administration of study drug
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Measured: up to 144 hours after last administration of study drug
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Measured: up to 144 hours after last administration of study drug
Apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration (Vz/F,ss)
Measured: up to 144 hours after last administration of study drug
Accumulation ratio of the analyte in plasma based on AUC over a uniform dosing interval after the first and last doses (RA, AUC)
Measured: up to 15 days after first administration of study drug
Accumulation ratio of the analyte in plasma based on Cmax over a uniform dosing interval after the last and first doses (RA,Cmax)
Measured: up to 15 days after first administration of study drug
Number of subjects with adverse events
Measured: up to 80 days
Assessment of tolerability by investigator on a 4-point scale
Measured: within 14 days after last trial procedure
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 startMay 2006
- Primary completionAug 2006
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
- 38 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
- NCT02259816
- Sponsor's protocol ID
- 1235.2
- 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
- Pharmacokinetics of Repeated Oral Doses of 80 mg Telmisartan (Micardis®) at Steady State Alone and in Combination With Repeated Oral Doses of Amlodipine 10 mg (Norvasc®) at Steady State. A Two-way Crossover, Open, Randomised Design Study
- ClinicalTrials.gov ID
- NCT02259816
- Acronym / sponsor ID
- 1235.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2006 (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 steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Active comparator | Drug: Telmisartan |
| Telmisartan and amlodipine | Experimental | Drug: Telmisartan, Drug: Amlodipine |
Who may qualify
- Ages
- 18 to 50 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 Age ≤50 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 (30 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 |
|---|---|---|
| TelmisartanAlso: Micardis® | Drug | Telmisartan, Telmisartan and amlodipine |
| AmlodipineAlso: Norvasc® | Drug | Telmisartan and amlodipine |
Primary outcome
Area under the concentration-time curve of telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: up to 15 days after first administration of study drug
Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: up to 15 days after first administration of study drug
17 secondary outcomes
AUCτ,ss for amlodipine
Time frame: up to 15 days after first administration of study drug
Cmax,ss for amlodipine
Time frame: up to 15 days after first administration of study drug
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 12 hours after first administration of study drug
Time from dosing to maximum measured concentration on plasma (tmax)
Time frame: up to 12 hours after first administration of study drug
Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)
Time frame: up to 12 hours after first administration of study drug
Pre-dose concentration of the analyte in plasma immediately before the administration of the next dose N (Cpre,N)
Time frame: pre-dose on days 2-9
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: up to 144 hours after last administration of study drug
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 144 hours after last administration of study drug
Terminal rate constant in plasma at steady state (λz,ss)
Time frame: up to 144 hours after last administration of study drug
Terminal half-life of the analyte in plasma at steady state (t1/2, ss)
Time frame: up to 144 hours after last administration of study drug
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Time frame: up to 144 hours after last administration of study drug
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time frame: up to 144 hours after last administration of study drug
Apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration (Vz/F,ss)
Time frame: up to 144 hours after last administration of study drug
Accumulation ratio of the analyte in plasma based on AUC over a uniform dosing interval after the first and last doses (RA, AUC)
Time frame: up to 15 days after first administration of study drug
Accumulation ratio of the analyte in plasma based on Cmax over a uniform dosing interval after the last and first doses (RA,Cmax)
Time frame: up to 15 days after first administration of study drug
Number of subjects with adverse events
Time frame: up to 80 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 14 days after last trial procedure
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.
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 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 30 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 telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) (time frame: up to 15 days after first 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.