HealthyPhase 1NCT02121535

Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use

A Phase 1 study testing T80/A5 mg FDC tablet, H12.5 mg tablet and T80/A5/H12.5 ng FDC tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: T80/A5 mg FDC tablet, H12.5 mg tablet and T80/A5/H12.5 ng FDC tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteJapan
Study dates: Apr 2014to Aug 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 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

Boehringer Ingelheim Investigational Site
Kanagawa, Yokohama

Other trials in Japan

About this study

Official title: Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Hydrochlorothiazide 12.5 mg Tablet in Healthy Male Subjects : an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study

The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.

Conditions: Healthy
Being tested: T80/A5 mg FDC tablet, H12.5 mg tablet, T80/A5/H12.5 ng FDC tablet, H12.5 mf tablet, T80/A5/H12.5 mg FDC tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T80/A5 mg FDC tabletDrug
T80/A5 mg FDC tabletDrug
A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet
H12.5 mg tabletDrug
T80/A5/H12.5 ng FDC tabletDrug
A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet
H12.5 mf tabletDrug
A HCTZ 12.5 mg tablet
T80/A5/H12.5 mg FDC tabletDrug

Study groups in NCT02121535
Study group	Role	What they receive
T80/A5/H12.5 mg FDC	Experimental	A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet Receives: Drug: T80/A5 mg FDC tablet; Drug: H12.5 mg tablet; Drug: T80/A5/H12.5 mg FDC tablet
T80/A5 mg FDC+H12.5 mg mono	Active comparator	A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet Receives: Drug: T80/A5 mg FDC tablet; Drug: T80/A5/H12.5 ng FDC tablet; Drug: H12.5 mf tablet

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 Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Measured: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
Cmax for Telmisartan
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
AUC0-tz for Amlodipine
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: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
Cmax for Amlodipine
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
Cmax for Hydrochlorothiazide
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration
AUC0-tz for Hydrochlorothiazide
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: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration

Secondary outcomes (3)

AUC0-∞ for Telmisartan
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
AUC0-∞ for Amlodipine
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
AUC0-∞ for Hydrochlorothiazide
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Aug 2014

First posted23 Apr 2014 (estimated)
Study startApr 2014
Primary completionAug 2014
Study completionAug 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: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02121535
Sponsor's protocol ID: 1348.3
Status last verified: Mar 2017
First submitted: 22 Apr 2014
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Hydrochlorothiazide 12.5 mg Tablet in Healthy Male Subjects : an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study
ClinicalTrials.gov ID: NCT02121535
Acronym / sponsor ID: 1348.3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 23 Apr 2014 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
T80/A5/H12.5 mg FDC	Experimental	Drug: T80/A5 mg FDC tablet, Drug: H12.5 mg tablet, Drug: T80/A5/H12.5 mg FDC tabletA Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet
T80/A5 mg FDC+H12.5 mg mono	Active comparator	Drug: T80/A5 mg FDC tablet, Drug: T80/A5/H12.5 ng FDC tablet, Drug: H12.5 mf tabletA Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy 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
T80/A5 mg FDC tablet	Drug	T80/A5/H12.5 mg FDC
T80/A5 mg FDC tabletA Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet	Drug	T80/A5 mg FDC+H12.5 mg mono
H12.5 mg tablet	Drug	T80/A5/H12.5 mg FDC
T80/A5/H12.5 ng FDC tabletA Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet	Drug	T80/A5 mg FDC+H12.5 mg mono
H12.5 mf tabletA HCTZ 12.5 mg tablet	Drug	T80/A5 mg FDC+H12.5 mg mono
T80/A5/H12.5 mg FDC tablet	Drug	T80/A5/H12.5 mg FDC

Primary outcome

Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)
Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Cmax for Telmisartan
Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
AUC0-tz for Amlodipine
Time frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
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)
Cmax for Amlodipine
Time frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Cmax for Hydrochlorothiazide
Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
AUC0-tz for Hydrochlorothiazide
Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration
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)

3 secondary outcomes

AUC0-∞ for Telmisartan
Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
AUC0-∞ for Amlodipine
Time frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
AUC0-∞ for Hydrochlorothiazide
Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence TRRT	36	36
Sequence RTTR	36	35

Primary outcome: Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)

Time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Test Treatment n = 71	Reference Treatment n = 71
Value	2850 (52.0)	2790 (54.9)

Test Treatment vs Reference Treatment: Adjusted Mean Ratio: 101.97 (90% CI 98.94 to 105.08)

Population analysed: Pharmacokinetic set (PKS): included all subjects in the TS who had evaluable pharmacokinetic (PK) variables for both test drug and reference drugs. Subjects who had an important protocol violation (PV) for relevant PK evaluation were excluded from the PKS.

Primary outcome: Cmax for Telmisartan

Measure	Test Treatment n = 71	Reference Treatment n = 71
Value	718 (56.4)	694 (55.2)

Test Treatment vs Reference Treatment: Adjusted Mean Ratio: 103.77 (90% CI 97.03 to 110.99)

Population analysed: PKS

Primary outcome: AUC0-tz for Amlodipine

Time frame: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Test Treatment n = 71	Reference Treatment n = 71
Value	171 (24.3)	172 (25.0)

Test Treatment vs Reference Treatment: Adjusted Mean Ratio: 99.50 (90% CI 98.08 to 100.94)

Population analysed: PKS

Primary outcome: Cmax for Amlodipine

Measure	Test Treatment n = 71	Reference Treatment n = 71
Value	3.69 (22.0)	3.68 (20.7)

Test Treatment vs Reference Treatment: Adjusted Mean Ratio: 100.07 (90% CI 98.45 to 101.72)

Population analysed: PKS

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events occurring after the first study drug administration till the end of treatment (EOT) (EOT: 144 hours after drug administration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Treatment	0 of 71 (0%)	0 of 71 (0%)	Not reported
Reference Treatment	0 of 72 (0%)	0 of 72 (0%)	Not reported
Total (All Patients)	0 of 72 (0%)	0 of 72 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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 T80/A5 mg FDC tablet, H12.5 mg tablet and T80/A5/H12.5 ng FDC tablet 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 12 Apr 2017. 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 12 Apr 2017). 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?

Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) (time frame: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after 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?

On the ClinicalTrials.gov record for NCT02121535.

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 12 Apr 2017.