HealthyPhase 1NCT02739672
Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
A Phase 1 study testing TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide), TWYNSTA(Telmisartan+Amlodipine besylate) and Hydrochlorothiazide in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
randomized, open-label, single dose, replicate crossover clinical trial to compare the pharmacokinetics of TAH tablet in comparison to the co-administration of telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide), TWYNSTA(Telmisartan+Amlodipine besylate) and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2016to 6 Apr 2016
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 19 to 55 years
- body mass index (BMI) of 17.5-30.5kg/m2 and weigh more than 55kg
- Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam. 5) willing and able to provide written informed consent
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- History of regular alcohol consumption (> 210 g/week) within the 6 months before the screening visit.
- Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- Seated systolic blood pressure <100mmHg or ≥ 150 mmHg , or diastolic blood pressure of <600mmHg or ≥ 100mmHg at the screening visit
- History of alcohol or drug abuse within the 12 months before the screening visit
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- Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- Smoker who smoke more than 20 cigarettes per day
- Subjects who take ethical the count or over the count medicine within 10days before the first investigational product administration.
- Blood Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
- Subjects 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.
- Subject with known for hypersensitivity reaction to TWYNSTA TAB or dihydropyridine derivatives
- Subject with known for hypersensitivity reaction to thiazide diuretics or Sulfonamides
- Patients with biliary obstructive disorder
- Patients receiving other drugs that affect RAAS such as Angiotensin Receptor Blocker(ARB), ACE inhibitors or aliskiren
- Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
- Patients with severe hepatic impairment
- Patients with severe aortic stenosis
- Patients with history of shock
- Patients with anuria
- Patients with acute or severe renal failure
- Patients with hyponatraemia hypokalemia
- Patients with Addison's disease
- Patients with hypercalcemia of malignancy
- Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
- Test subjects who is not willing or unable to comply with guidelines described in this protocol
- A person who is not determined unsuitable to participate in this test by the researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
randomized, open-label, single dose, replicate crossover clinical trial to compare the pharmacokinetics of TAH tablet in comparison to the co-administration of telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers
- Conditions
- Healthy
- Being tested
- TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide), TWYNSTA(Telmisartan+Amlodipine besylate), Hydrochlorothiazide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide)Drug
Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 25 mg combination-drug would be administered orally once
TWYNSTA(Telmisartan+Amlodipine besylate)Drug
TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once
HydrochlorothiazideDrug
Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once
| Study group | Role | What they receive |
|---|---|---|
| TAH tablet | Experimental | Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet Receives: Drug: TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide) |
| Telmisartan+Amlodipine besylate+Hydrochlorothiazide | Active comparator | coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide Receives: Drug: TWYNSTA(Telmisartan+Amlodipine besylate); 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, 144(Total 18 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, 144 (Total 18 points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start2 Jan 2016
- Primary completion6 Apr 2016
- Study completion6 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 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
- NCT02739672
- Sponsor's protocol ID
- ID-TAH-102
- Status last verified
- Apr 2016
- First submitted
- 31 Mar 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02739672
- Acronym / sponsor ID
- ID-TAH-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 6 Apr 2016 (actual)
- Study completion
- 6 Apr 2016 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
randomized, open-label, single dose, replicate crossover clinical trial to compare the pharmacokinetics of TAH tablet in comparison to the co-administration of 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
- 2
| Arm | Type | Receives |
|---|---|---|
| TAH tablet | Experimental | Drug: TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide)Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet |
| Telmisartan+Amlodipine besylate+Hydrochlorothiazide | Active comparator | Drug: TWYNSTA(Telmisartan+Amlodipine besylate), Drug: Hydrochlorothiazidecoadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers aged 19 to 55 years
- body mass index (BMI) of 17.5-30.5kg/m2 and weigh more than 55kg
- Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam. 5) willing and able to provide written informed consent
Key exclusion criteria (27 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- History of regular alcohol consumption (> 210 g/week) within the 6 months before the screening visit.
- Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- Seated systolic blood pressure <100mmHg or ≥ 150 mmHg , or diastolic blood pressure of <600mmHg or ≥ 100mmHg at the screening visit
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 |
|---|---|---|
| TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide)Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 25 mg combination-drug would be administered orally once | Drug | TAH tablet |
| TWYNSTA(Telmisartan+Amlodipine besylate)TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once | Drug | Telmisartan+Amlodipine besylate+Hydrochlorothiazide |
| HydrochlorothiazideDichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once | Drug | Telmisartan+Amlodipine besylate+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, 144(Total 18 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, 144 (Total 18 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 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide), TWYNSTA(Telmisartan+Amlodipine besylate) and Hydrochlorothiazide in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
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 27 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 Jan 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 South Korea. 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?
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, 144(Total 18 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?
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 Jan 2017.