HealthyPhase 1NCT01344629

Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

A Phase 1 study testing Telmisartan/Amlodipin FDC, Telmisartan and Amlodipin 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

To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use 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/Amlodipin FDC, Telmisartan and Amlodipin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteJapan
Study dates: Apr 2011to Jul 2011
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

Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
Age: =20 and =35 years
Body weight: =50 kg and =80 kg
Body mass index (BMI): =18.0 and =25.0 kg/m2

Who cannot join

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
Chronic or relevant acute infections
Any clinical relevant findings in laboratory test results deviating from normal
A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
History of surgery of the gastrointestinal tract (except appendectomy)

Show all 19Show fewer

History of relevant orthostatic hypotension, fainting spells, or blackouts
Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin receptor blocker, or to any other dihydropyridine calcium channel blocker compound
Intake of drugs with a long half-life (=24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration
Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration
Participation in another trial with an investigational drug within 1 months or less than 10 times of half-lives of the investigational products before drug administration
Smoker (=20 cigarettes/day)
Alcohol abuse (60 g or more ethanol/day: e.g., 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 before drug administration)
Excessive physical activities (ex. Marathon etc) within 1 week before drug administration
Intake of alcohol within 2 days before drug administration
Inability to comply with dietary regimen of the study site
Inability to refrain from smoking during trial days

Trial locations and contacts

1 site in 1 country.

Japan1 site

1235.28.001 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto

Other trials in Japan

About this study

Official title: Bioequivalence of Telmisartan Administrated in Two Different Ways: Both in Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg Tablet and Amlodipine 5mg Tablet in Concomitant Use in Healthy Male Volunteers. (an Open-label, Randomized, Single-dose, Four-period Replicated Crossover Study)

Read the detailed description

Purpose:

Conditions: Healthy
Being tested: Telmisartan/Amlodipin FDC, Telmisartan, Amlodipin

What participants receive

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

Telmisartan/Amlodipin FDCDrug
Telmisartan80mg/Amlodipin5mg FDC
TelmisartanDrug
Telmisartan 80 mg tablet
AmlodipinDrug
Amlodipin 5mg tablet

Study groups in NCT01344629
Study group	Role	What they receive
Telmisartan80mg/Amlodipin5mg FDC	Experimental	single-dose, four-period replicated crossover design Receives: Drug: Telmisartan/Amlodipin FDC
Telmisartan80mgtab + Amlodipin5mg tab	Experimental	single-dose, four-period replicated crossover design Receives: Drug: Telmisartan; Drug: Amlodipin

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-tz
Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Cmax
maximum measured concentration of Telmisartan in plasma
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Secondary outcomes (5)

AUC0-∞
area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Tmax
time from dosing to the maximum concentration of Telmisartan in plasma
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
λz
terminal rate constant of Telmisartan in plasma
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
t1/2
terminal half-life of Telmisartan in plasma
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
MRTpo
mean residence time of Telmisartan in the body after oral administration
Measured: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours 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 2011Jul 2011

First posted29 Apr 2011 (estimated)
Study startApr 2011
Primary completionJul 2011

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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01344629
Sponsor's protocol ID: 1235.28
Status last verified: Feb 2014
First submitted: 26 Apr 2011
Last updated: 28 Mar 2014
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 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of Telmisartan Administrated in Two Different Ways: Both in Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg Tablet and Amlodipine 5mg Tablet in Concomitant Use in Healthy Male Volunteers. (an Open-label, Randomized, Single-dose, Four-period Replicated Crossover Study)
ClinicalTrials.gov ID: NCT01344629
Acronym / sponsor ID: 1235.28
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jul 2011 (actual)
First posted: 29 Apr 2011 (estimated)
Results: Posted 27 Aug 2012

Clinical summary

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

Detailed description

Purpose:

Study design

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

Arm	Type	Receives
Telmisartan80mg/Amlodipin5mg FDC	Experimental	Drug: Telmisartan/Amlodipin FDCsingle-dose, four-period replicated crossover design
Telmisartan80mgtab + Amlodipin5mg tab	Experimental	Drug: Telmisartan, Drug: Amlodipinsingle-dose, four-period replicated crossover design

Who may qualify

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

Key inclusion criteria (4 listed)

Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
Age: =20 and =35 years
Body weight: =50 kg and =80 kg
Body mass index (BMI): =18.0 and =25.0 kg/m2

Key exclusion criteria (19 listed)

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
Chronic or relevant acute infections
Any clinical relevant findings in laboratory test results deviating from normal
A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an 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/Amlodipin FDCTelmisartan80mg/Amlodipin5mg FDC	Drug	Telmisartan80mg/Amlodipin5mg FDC
TelmisartanTelmisartan 80 mg tablet	Drug	Telmisartan80mgtab + Amlodipin5mg tab
AmlodipinAmlodipin 5mg tablet	Drug	Telmisartan80mgtab + Amlodipin5mg tab

Primary outcome

AUC0-tz
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point
Cmax
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
maximum measured concentration of Telmisartan in plasma

5 secondary outcomes

AUC0-∞
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Tmax
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
λz
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
t1/2
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
MRTpo
Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Results and safety

Results posted to the registry on 27 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A	32	32
Treatment Sequence B	32	32

Primary outcome: AUC0-tz

Time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hour/mL

Measure	T80/A5 mg FDC Tablet n = 126	T80mg Tablet and A5 mg Tablet in Concomitant Use n = 126
Value	1970 (67.9)	1950 (67.0)

T80/A5 mg FDC Tablet vs T80mg Tablet and A5 mg Tablet in Concomitant Use: Test/Reference Ratio of the mean x 100: 100.9 (90% CI 97.7 to 104.2), ANOVA

Population analysed: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.

Primary outcome: Cmax

Measure	T80/A5 mg FDC Tablet n = 126	T80mg Tablet and A5 mg Tablet in Concomitant Use n = 126
Value	471 (88.1)	484 (81.8)

T80/A5 mg FDC Tablet vs T80mg Tablet and A5 mg Tablet in Concomitant Use: Test/Reference Ratio of the mean x 100: 97.2 (90% CI 87.2 to 108.3), ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent onwards through the observational phase. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Sequence A	0 of 32 (0%)	0 of 32 (0%)	Not reported
Treatment Sequence B	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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/Amlodipin FDC, Telmisartan and Amlodipin 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 4 inclusion and 19 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 Mar 2014. 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 27 Aug 2012). 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?

AUC0-tz (time frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 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?

On the ClinicalTrials.gov record for NCT01344629.

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 Mar 2014.