HealthyPhase 1NCT02183675
Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers
A Phase 1 study testing Telmisartan/Amlodipine, Telmisartan/Amlodipine/HCTZ and Telmisartan/HCTZ in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects 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, Telmisartan/Amlodipine/HCTZ and Telmisartan/HCTZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Japanese male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
- Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
- Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.
Who cannot join
- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.
Trial locations and contacts
1 site in 1 country.
Japan1 site
1348.5.001 Boehringer Ingelheim Investigational Site
Kanagawa , Yokohama
About this study
Official title: Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence Crossover Study
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects
- Conditions
- Healthy
- Being tested
- Telmisartan/Amlodipine, Telmisartan/Amlodipine/HCTZ, Telmisartan/HCTZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/AmlodipineDrug
Telmisartan/Amlodipine fixed-dose combination
Telmisartan/Amlodipine/HCTZDrug
Telmisartan/Amlodipine/HCTZ fixed-dose combination
Telmisartan/HCTZDrug
Telmisartan/HCTZ fixed-dose combination
| Study group | Role | What they receive |
|---|---|---|
| T/A/H | Experimental | Telmisartan/Amlodipine/HCTZ fixed-dose combination Receives: Drug: Telmisartan/Amlodipine/HCTZ |
| T/A | Active comparator | Telmisartan/Amlodipine fixed-dose combination Receives: Drug: Telmisartan/Amlodipine |
| T/H | Active comparator | Telmisartan/HCTZ fixed-dose combination Receives: Drug: Telmisartan/HCTZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Measured Concentration (Cmax) at Steady State for Telmisartan
Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau
Measured: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
Area Under the Plasma Concentration Curve at Steady State for Telmisartan
Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau
Measured: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
Maximum Measured Concentration (Cmax) at Steady State for Amlodipine
Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau
Measured: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
Area Under the Plasma Concentration Curve at Steady State for Amlodipine
Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau
Measured: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
Maximum Measured Concentration (Cmax) at Steady State for HCTZ
Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau
Measured: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
Area Under the Plasma Concentration Curve at Steady State for HCTZ
Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau
Measured: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
Secondary outcomes (1)
Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours
Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state
Measured: 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183675
- Sponsor's protocol ID
- 1348.5
- Status last verified
- Oct 2016
- First submitted
- 7 Jul 2014
- Last updated
- 30 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence Crossover Study
- ClinicalTrials.gov ID
- NCT02183675
- Acronym / sponsor ID
- 1348.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Posted 30 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T/A/H | Experimental | Drug: Telmisartan/Amlodipine/HCTZTelmisartan/Amlodipine/HCTZ fixed-dose combination |
| T/A | Active comparator | Drug: Telmisartan/AmlodipineTelmisartan/Amlodipine fixed-dose combination |
| T/H | Active comparator | Drug: Telmisartan/HCTZTelmisartan/HCTZ fixed-dose combination |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
- Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
- Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.
Key exclusion criteria (1 listed)
- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.
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/AmlodipineTelmisartan/Amlodipine fixed-dose combination | Drug | T/A |
| Telmisartan/Amlodipine/HCTZTelmisartan/Amlodipine/HCTZ fixed-dose combination | Drug | T/A/H |
| Telmisartan/HCTZTelmisartan/HCTZ fixed-dose combination | Drug | T/H |
Primary outcome
Maximum Measured Concentration (Cmax) at Steady State for Telmisartan
Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau
Area Under the Plasma Concentration Curve at Steady State for Telmisartan
Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau
Maximum Measured Concentration (Cmax) at Steady State for Amlodipine
Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau
Area Under the Plasma Concentration Curve at Steady State for Amlodipine
Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau
Maximum Measured Concentration (Cmax) at Steady State for HCTZ
Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau
Area Under the Plasma Concentration Curve at Steady State for HCTZ
Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau
1 secondary outcome
Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours
Time frame: 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telmisartan/Amlodipine, Telmisartan/Amlodipine/HCTZ and Telmisartan/HCTZ in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
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 3 inclusion and 1 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Measured Concentration (Cmax) at Steady State for Telmisartan (time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration). The study lists 6 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 30 Nov 2016.