HealthyPhase 1NCT03889145
A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide
A Phase 1 study testing Telmisartan 80mg, Amlodipine10mg and Hydrochlorothiazide in people with Healthy, run by IlDong Pharmaceutical Co Ltd.
Trial summary
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs interaction between Telmisartan, Amlodipine and Hydrochlorothiazide in healthy male volunteers Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan 80mg, Amlodipine10mg and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2013to 19 Feb 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 20 to 55 years
- Subjects who have 17.5 ~ 30.5 kg/m2 body mass index (BMI) and body weight that is more than 55kg
- Subjects who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination.
- Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as electrocardiography(ECG) test.
- Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital Institutional Review Board(IRB).
Who cannot join
- Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who involved in other clinical trials within two months before the first dose medication characters.
- Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening
- Subjects who had alcohol or drug abuse within one year before the screening
Show all 24Show fewer
- Subjects who took medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
- Subjects who smoke 20 cigarettes or more a day
- Subjects who take medicine within 10 days before the first investigational product administration.
- Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
- Subject who can increase risk due to clinical test and administration of drugs or has severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- Subjects with serious history of hypersensitivity or allergy to investigational product.
- Subjects with severe hepatic impairment or Gallbladder Disease.
- Subject with hereditary angioedema or a history of angioedema when treated with ACE(Angiotensin-Converting enzyme) inhibitor or ARB(Angiotensin II Receptor Blocker) therapy
- Subjects who take combination medication with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
- Subjects with severe hepatic impairment
- Subjects who have severe aortic stenosis
- Subjects with acute or severe renal failure
- Subjects with hyponatremia or hypokalemia
- Subjects with Addison's disease
- Subjects with hypercalcemia
- Subjects who have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects who are unwilling or unable to comply with the Lifestyle guidelines described in this protocol
- Subject who are inadequate for this study to participate judged by investigator
About this study
Official title: A Randomized, Open-label, Single Dose, 3-way Crossover Study to Evaluate the Drug-drugs Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs interaction between Telmisartan, Amlodipine and Hydrochlorothiazide in healthy male volunteers
- Conditions
- Healthy
- Being tested
- Telmisartan 80mg, Amlodipine10mg, Hydrochlorothiazide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan 80mgDrug
Telmisartan 80mg
Amlodipine10mgDrug
Amlodipine 10mg
HydrochlorothiazideDrug
Hydrochlorothiazide 25mg
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan, Amlodipine | Active comparator | Not described Receives: Drug: Telmisartan 80mg; Drug: Amlodipine10mg |
| Hydrochlorothiazide | Active comparator | Not described Receives: Drug: Hydrochlorothiazide |
| Telmisartan, Amlodipine, Hydrochlorothiazide | Experimental | Not described Receives: Drug: Telmisartan 80mg; Drug: Amlodipine10mg; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
Cmax
Measured: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
Secondary outcomes (2)
AUCinf
Measured: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
Tmax
Measured: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start19 Dec 2013
- Primary completion19 Feb 2014
- Study completion19 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889145
- Sponsor's protocol ID
- ID-TAH-1301
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moon SJ, Jeon JY, Yu KS, Kim MG. Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects. Clin Ther. 2019 Nov;41(11):2273-2282. doi: 10.1016/j.clinthera.2019.08.020. Epub 2019 Sep 26.
PubMed 31564513
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 3-way Crossover Study to Evaluate the Drug-drugs Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03889145
- Acronym / sponsor ID
- ID-TAH-1301
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2013 (actual)
- Primary completion
- 19 Feb 2014 (actual)
- Study completion
- 19 Feb 2014 (actual)
- First posted
- 26 Mar 2019 (actual)
- 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.
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs interaction between Telmisartan, Amlodipine and Hydrochlorothiazide in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telmisartan, Amlodipine | Active comparator | Drug: Telmisartan 80mg, Drug: Amlodipine10mg |
| Hydrochlorothiazide | Active comparator | Drug: Hydrochlorothiazide |
| Telmisartan, Amlodipine, Hydrochlorothiazide | Experimental | Drug: Telmisartan 80mg, Drug: Amlodipine10mg, Drug: Hydrochlorothiazide |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers aged 20 to 55 years
- Subjects who have 17.5 ~ 30.5 kg/m2 body mass index (BMI) and body weight that is more than 55kg
- Subjects who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination.
- Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as electrocardiography(ECG) test.
- Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital Institutional Review Board(IRB).
Key exclusion criteria (24 listed)
- Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who involved in other clinical trials within two months before the first dose medication characters.
- Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening
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 80mgTelmisartan 80mg | Drug | Telmisartan, Amlodipine, Telmisartan, Amlodipine, Hydrochlorothiazide |
| Amlodipine10mgAmlodipine 10mg | Drug | Telmisartan, Amlodipine, Telmisartan, Amlodipine, Hydrochlorothiazide |
| HydrochlorothiazideHydrochlorothiazide 25mg | Drug | Hydrochlorothiazide, Telmisartan, Amlodipine, Hydrochlorothiazide |
Primary outcome
AUClast
Time frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
Cmax
Time frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
2 secondary outcomes
AUCinf
Time frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
Tmax
Time frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]
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 26 Mar 2019.
- Derived from this study: PubMed 31564513Moon SJ, Jeon JY, Yu KS, Kim MG. Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects. Clin Ther. 2019 Nov;41(11):2273-2282. doi: 10.1016/j.clinthera.2019.08.020. Epub 2019 Sep 26.
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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.
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 80mg, Amlodipine10mg and Hydrochlorothiazide in people with Healthy, run by IlDong Pharmaceutical Co Ltd.
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 5 inclusion and 24 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 26 Mar 2019. 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?
AUClast (time frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144(Total 19 points)]). 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 NCT03889145, which also lists 1 linked publication.
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 26 Mar 2019.