HealthyPhase 1NCT01181011

Telmisartan, Amlodipine and Combination in Healthy Subjects

A Phase 1 study testing amlodipine/telmisartan/combination in people with Healthy, run by Boehringer Ingelheim at 1 site in China.

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 determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects. To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: amlodipine/telmisartan/combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: Aug 2010to Nov 2010
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females
Aged between 18 and 45 years
Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2

Who cannot join

Any finding of the medical examination deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.

Show all 25Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
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
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker
Inability to refrain from smoking during 24 hours prior to dosing and during the trial
Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A history of additional risk factors for torsade de pointes
Any history of relevant low blood pressure
Supine blood pressure at screening of systolic <110 mm Hg and diastolic < 60 mm Hg
History of urticaria
History of angioneurotic edema 25 Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
26. No adequate contraception during the study and until 1 month of study completion 27. Lactation period

Trial locations and contacts

1 site in 1 country.

China1 site

1235.30.86001 Boehringer Ingelheim Investigational Site
Shanghai

Other trials in China

About this study

Official title: A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects

To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.

To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects.

To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.

Conditions: Healthy
Being tested: amlodipine/telmisartan/combination

What participants receive

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

amlodipine/telmisartan/combinationDrug
patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.

Study groups in NCT01181011
Study group	Role	What they receive
amlodipine/telmisartan/combination	Experimental	all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order Receives: Drug: amlodipine/telmisartan/combination

What is being measured

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

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 (AUC_0-tz)
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
The Maximum Observed Plasma Concentration (Cmax) of Telmisartan
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-tz of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-∞ of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Cmax of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs

Secondary outcomes (14)

Time to Attain Cmax (Tmax) of Telmisartan
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Terminal Rate Constant in Plasma (λz) of Telmisartan
reflect the speed of drug elimination in vivo
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Elimination Half-life (t_½) of Telmisartan
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Tmax of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
λz of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
MRT_po of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
t_½ of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
CL/F of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
V_z/F of Amlodipine
Measured: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Number of Participants With at Least One Treatment Emergent Adverse Event
Measured: 4 weeks
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
Measured: 4 weeks

Timeline

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

Aug 2010Nov 2010

First posted13 Aug 2010 (estimated)
Study startAug 2010
Primary completionNov 2010

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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181011
Sponsor's protocol ID: 1235.30
Status last verified: Jul 2014
First submitted: 10 Aug 2010
Last updated: 24 Jul 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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT01181011
Acronym / sponsor ID: 1235.30
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Nov 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 10 May 2012

Clinical summary

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

To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.

To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
amlodipine/telmisartan/combination	Experimental	Drug: amlodipine/telmisartan/combinationall patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy males and females
Aged between 18 and 45 years
Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2

Key exclusion criteria (25 listed)

Any finding of the medical examination deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system 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
amlodipine/telmisartan/combinationpatient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.	Drug	amlodipine/telmisartan/combination

Primary outcome

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 (AUC_0-tz)
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
The Maximum Observed Plasma Concentration (Cmax) of Telmisartan
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-tz of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-∞ of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Cmax of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs

14 secondary outcomes

Time to Attain Cmax (Tmax) of Telmisartan
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Terminal Rate Constant in Plasma (λz) of Telmisartan
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Elimination Half-life (t_½) of Telmisartan
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Tmax of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
λz of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
MRT_po of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
t_½ of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
CL/F of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
V_z/F of Amlodipine
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Number of Participants With at Least One Treatment Emergent Adverse Event
Time frame: 4 weeks
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
Time frame: 4 weeks

Results and safety

Results posted to the registry on 10 May 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
All Participants	28	25

Primary outcome: 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 (AUC_0-tz)

Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs. Geometric mean (Geometric Coefficient of Variation). Unit: ng·h/mL

Measure	Telmisartan 80mg, Amlodipine 5mg n = 27	Telmisartan 80mg n = 27
Value	3200 (74.7)	2940 (94.4)

Telmisartan 80mg, Amlodipine 5mg vs Telmisartan 80mg: gMean Ratio: 109.22 (90% CI 99.45 to 119.95), p = 0.0107, ANCOVA

Population analysed: All patients with values for AUC\_0-tz of Telmisartan

Primary outcome: Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan

Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs. Geometric mean (Geometric Coefficient of Variation). Unit: ng·h/mL

Measure	Telmisartan 80mg, Amlodipine 5mg n = 27	Telmisartan 80mg n = 27
Value	3420 (82.5)	3140 (98.5)

Telmisartan 80mg, Amlodipine 5mg vs Telmisartan 80mg: gMean Ratio: 109.84 (90% CI 99.96 to 120.71), p = 0.0139, ANCOVA

Population analysed: All patients with values for AUC\_0-∞ of Telmisartan

Primary outcome: The Maximum Observed Plasma Concentration (Cmax) of Telmisartan

Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Telmisartan 80mg, Amlodipine 5mg n = 27	Telmisartan 80mg n = 27
Value	461 (59.9)	480 (78.3)

Telmisartan 80mg, Amlodipine 5mg vs Telmisartan 80mg: gMean Ratio: 97.57 (90% CI 84.643 to 112.472), p = 0.0126, ANCOVA

Population analysed: All patients with values for Cmax of Telmisartan

Primary outcome: AUC_0-tz of Amlodipine

Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs. Geometric mean (Geometric Coefficient of Variation). Unit: ng·h/mL

Measure	Telmisartan 80mg, Amlodipine 5mg n = 27	Amlodipine 5mg n = 25
Value	206 (28.6)	192 (31)

Telmisartan 80mg, Amlodipine 5mg vs Amlodipine 5mg: gMean Ratio: 109.7 (90% CI 102.87 to 117.07), p = 0.0011, ANCOVA

Population analysed: All patients with values for AUC\_0-tz of Amlodipine

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan 80mg, Amlodipine 5mg	0 of 27 (0%)	2 of 27 (7.4%)	Not reported
Telmisartan 80mg	0 of 27 (0%)	1 of 27 (3.7%)	Not reported
Amlodipine 5mg	0 of 26 (0%)	3 of 26 (11.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 amlodipine/telmisartan/combination in people with Healthy, run by Boehringer Ingelheim at 1 site in China.

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 25 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 24 Jul 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 China. 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 10 May 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?

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 (AUC_0-tz) (time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs). 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 NCT01181011.

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 24 Jul 2014.