HealthyPhase 1NCT02262572
Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects
A Phase 1 study testing Telmisartan /HCTZ - compression tablet (DC), Telmisartan /HCTZ - dry granulation tablet (DG) and Telmisartan /HCTZ - present commercial formulation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®) Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan /HCTZ - compression tablet (DC), Telmisartan /HCTZ - dry granulation tablet (DG) and Telmisartan /HCTZ - present commercial formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Aug 2003
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting the following criteria will be eligible for participation in the study:
- Healthy male and female subjects according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests.
- Laboratory values within a clinically defined reference range
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and Age <=55 years
- Body mass index (BMI) >=18.5 and <=29.9 kg/m2
- Able to communicate well with the investigator and to comply with study requirements
- Good condition of veins
Who cannot join
- Any finding of the medical examination (including blood pressure, heart rate, and electrocardiogram) deviating from normal and of clinical relevance
- Supine blood pressure at screening of systolic ≤ 110 mm Hg and diastolic ≤ 60 mmHg
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of 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 27Show fewer
- Chronic or relevant acute infections
- History of an allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- 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 any drugs, which might reasonably influence the results of the trial 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 (more than 10 cigarettes or three cigars or three pipes/day)
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation or loss of more than 400 mL within four weeks prior to administration or during the trial
- Excessive physical activities (within five days prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- History of hereditary fructose intolerance
- Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
- Inability to comply with the dietary regimen of study centre
- Inability to comply with the investigator's instructions.
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Relative Bioavailability of Telmisartan and HCTZ p.o. (80 mg Telmisartan/12.5 mg HCTZ) in Two Experimental Formulations (Given t.i.d. for One Day Each) Compared to the Standard Formulation 80 mg Telmisartan/12.5 mg HCTZ (MicardisPlus®), Given t.i.d. for One Day in Healthy Female and Male Subjects. A Three-way Crossover, Open, Randomised Study
Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)
- Conditions
- Healthy
- Being tested
- Telmisartan /HCTZ - compression tablet (DC), Telmisartan /HCTZ - dry granulation tablet (DG), Telmisartan /HCTZ - present commercial formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan /HCTZ - compression tablet (DC)Drug
Telmisartan /HCTZ - dry granulation tablet (DG)Drug
Telmisartan /HCTZ - present commercial formulationDrug
Also called MicardisPlus®
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan /HCTZ - compression tablet (DC) | Experimental | Not described Receives: Drug: Telmisartan /HCTZ - compression tablet (DC) |
| Telmisartan /HCTZ - dry granulation tablet (DG) | Experimental | Not described Receives: Drug: Telmisartan /HCTZ - dry granulation tablet (DG) |
| Telmisartan /HCTZ - present commercial formulation | Active comparator | Not described Receives: Drug: Telmisartan /HCTZ - present commercial formulation |
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 72 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)
Measured: up to 48 hours after drug administration
Secondary outcomes (9)
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
t1/2 (Terminal half-life of the analyte in plasma)
Measured: up to 72 hours after drug administration
CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 72 hours after drug administration
MRTtot (Total mean residence time)
Measured: up to 72 hours after drug administration
Vz/F (Apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours after drug administration
Number of subjects with adverse events
Measured: up to 32 days
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Measured: up to 32 days
Number of subjects with clinically significant findings in 12 lead ECG
Measured: up to 32 days
Investigator's assessment of tolerability on a 4-point scale
Measured: up to 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startApr 2003
- Primary completionAug 2003
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
- 24 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
- NCT02262572
- Sponsor's protocol ID
- 502.415
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Telmisartan and HCTZ p.o. (80 mg Telmisartan/12.5 mg HCTZ) in Two Experimental Formulations (Given t.i.d. for One Day Each) Compared to the Standard Formulation 80 mg Telmisartan/12.5 mg HCTZ (MicardisPlus®), Given t.i.d. for One Day in Healthy Female and Male Subjects. A Three-way Crossover, Open, Randomised Study
- ClinicalTrials.gov ID
- NCT02262572
- Acronym / sponsor ID
- 502.415
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Aug 2003 (actual)
- First posted
- 13 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 assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telmisartan /HCTZ - compression tablet (DC) | Experimental | Drug: Telmisartan /HCTZ - compression tablet (DC) |
| Telmisartan /HCTZ - dry granulation tablet (DG) | Experimental | Drug: Telmisartan /HCTZ - dry granulation tablet (DG) |
| Telmisartan /HCTZ - present commercial formulation | Active comparator | Drug: Telmisartan /HCTZ - present commercial formulation |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and female subjects according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests.
- Laboratory values within a clinically defined reference range
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and Age <=55 years
- Body mass index (BMI) >=18.5 and <=29.9 kg/m2
Key exclusion criteria (27 listed)
- Any finding of the medical examination (including blood pressure, heart rate, and electrocardiogram) deviating from normal and of clinical relevance
- Supine blood pressure at screening of systolic ≤ 110 mm Hg and diastolic ≤ 60 mmHg
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of 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 /HCTZ - compression tablet (DC) | Drug | Telmisartan /HCTZ - compression tablet (DC) |
| Telmisartan /HCTZ - dry granulation tablet (DG) | Drug | Telmisartan /HCTZ - dry granulation tablet (DG) |
| Telmisartan /HCTZ - present commercial formulationAlso: MicardisPlus® | Drug | Telmisartan /HCTZ - present commercial formulation |
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 72 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)
Time frame: up to 48 hours after drug administration
9 secondary outcomes
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (Terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 72 hours after drug administration
MRTtot (Total mean residence time)
Time frame: up to 72 hours after drug administration
Vz/F (Apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to 32 days
Number of subjects with clinically significant findings in vital signs
Time frame: up to 32 days
Number of subjects with clinically significant findings in 12 lead ECG
Time frame: up to 32 days
Investigator's assessment of tolerability on a 4-point scale
Time frame: up to 32 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 13 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 /HCTZ - compression tablet (DC), Telmisartan /HCTZ - dry granulation tablet (DG) and Telmisartan /HCTZ - present commercial formulation 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 8 inclusion and 27 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 13 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?
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 72 hours after drug administration). The study lists 3 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 13 Oct 2014.