HealthyPhase 1NCT02276378
Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers
A Phase 1 study testing Telmisartan low, Telmisartan high and Hydrochlorothiazide (HCTZ) in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state 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 low, Telmisartan high and Hydrochlorothiazide (HCTZ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Aug 2008
- 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 (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with 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 disorders or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
- History of surgery of 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 hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
- 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
- Inability to refrain from smoking on trial days
- Subjects judged to be inappropriate by the investigator or the sub-investigator
About this study
Official title: Influence of Food on the Bioavailability of Telmisartan 40 mg/HCTZ 12.5 mg Fixed-dose Combination and of Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination in Japanese Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers
- Conditions
- Healthy
- Being tested
- Telmisartan low, Telmisartan high, Hydrochlorothiazide (HCTZ), Japanese meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan lowDrug
Telmisartan highDrug
Hydrochlorothiazide (HCTZ)Drug
Japanese mealOther
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan low / HCTZ fixed-dose combination, fed | Experimental | Not described Receives: Drug: Telmisartan low; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal |
| Telmisartan high / HCTZ fixed-dose combination, fed | Experimental | Not described Receives: Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal |
| Telmisartan low /HCTZ fixed-dose combination, fasted | Active comparator | Not described Receives: Drug: Telmisartan low; Drug: Hydrochlorothiazide (HCTZ) |
| Telmisartan high /HCTZ fixed-dose combination, fasted | Active comparator | Not described Receives: Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ) |
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 the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Measured: Up to 72 hours after drug administration
The maximum measured concentration of the analyte in the plasma (Cmax)
Measured: Up to 72 hours after drug administration
Secondary outcomes (10)
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 72 hours after drug administration
Time from dosing to the maximum concentration of the analyte in the plasma (tmax)
Measured: Up to 72 hours after drug administration
Terminal rate constant in the plasma (λz)
Measured: Up to 72 hours after drug administration
Terminal half-life of the analyte in the plasma (t1/2)
Measured: Up to 72 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Measured: Up to 72 hours after drug administration
Number of participants with abnormal findings in physical examination
Measured: Up to 72 hours after drug administration
Number of participants with clinically significant findings in vital signs
Measured: Up to 72 hours after last drug administration
Number of participants with clinically significant findings in 12-lead ECG
Measured: Up to 72 hours after drug administration
Number of participants with clinically significant findings in clinical laboratory parameters
Measured: Up to 72 hours after drug administration
Number of participants with adverse events
Measured: Up to 7 days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJul 2008
- Primary completionAug 2008
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
- NCT02276378
- Sponsor's protocol ID
- 502.569
- Status last verified
- Oct 2014
- First submitted
- 27 Oct 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 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/HCTZ 12.5 mg Fixed-dose Combination and of Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination in Japanese Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02276378
- Acronym / sponsor ID
- 502.569
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 28 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.
To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state 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 low / HCTZ fixed-dose combination, fed | Experimental | Drug: Telmisartan low, Drug: Hydrochlorothiazide (HCTZ), Other: Japanese meal |
| Telmisartan high / HCTZ fixed-dose combination, fed | Experimental | Drug: Telmisartan high, Drug: Hydrochlorothiazide (HCTZ), Other: Japanese meal |
| Telmisartan low /HCTZ fixed-dose combination, fasted | Active comparator | Drug: Telmisartan low, Drug: Hydrochlorothiazide (HCTZ) |
| Telmisartan high /HCTZ fixed-dose combination, fasted | Active comparator | Drug: Telmisartan high, Drug: Hydrochlorothiazide (HCTZ) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with 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 disorders or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or 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 low | Drug | Telmisartan low / HCTZ fixed-dose combination, fed, Telmisartan low /HCTZ fixed-dose combination, fasted |
| Telmisartan high | Drug | Telmisartan high / HCTZ fixed-dose combination, fed, Telmisartan high /HCTZ fixed-dose combination, fasted |
| Hydrochlorothiazide (HCTZ) | Drug | Telmisartan high / HCTZ fixed-dose combination, fed, Telmisartan high /HCTZ fixed-dose combination, fasted, Telmisartan low / HCTZ fixed-dose combination, fed, Telmisartan low /HCTZ fixed-dose combination, fasted |
| Japanese meal | Other | Telmisartan high / HCTZ fixed-dose combination, fed, Telmisartan low / HCTZ fixed-dose combination, fed |
Primary outcome
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Time frame: Up to 72 hours after drug administration
The maximum measured concentration of the analyte in the plasma (Cmax)
Time frame: Up to 72 hours after drug administration
10 secondary outcomes
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 72 hours after drug administration
Time from dosing to the maximum concentration of the analyte in the plasma (tmax)
Time frame: Up to 72 hours after drug administration
Terminal rate constant in the plasma (λz)
Time frame: Up to 72 hours after drug administration
Terminal half-life of the analyte in the plasma (t1/2)
Time frame: Up to 72 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: Up to 72 hours after drug administration
Number of participants with abnormal findings in physical examination
Time frame: Up to 72 hours after drug administration
Number of participants with clinically significant findings in vital signs
Time frame: Up to 72 hours after last drug administration
Number of participants with clinically significant findings in 12-lead ECG
Time frame: Up to 72 hours after drug administration
Number of participants with clinically significant findings in clinical laboratory parameters
Time frame: Up to 72 hours after drug administration
Number of participants with adverse events
Time frame: Up to 7 days after drug administration
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 28 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 low, Telmisartan high and Hydrochlorothiazide (HCTZ) 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 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 28 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 the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) (time frame: Up to 72 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 28 Oct 2014.