Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers

January 24, 2017 updated by: IlDong Pharmaceutical Co Ltd

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chonbuk, Korea, Republic of, 561-712
        • Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male volunteers aged 19 to 55 years
  2. body mass index (BMI) of 17.5-30.5kg/m2 and weigh more than 55kg
  3. Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
  4. 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

Exclusion Criteria:

  1. 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)
  2. 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
  3. History of regular alcohol consumption (> 210 g/week) within the 6 months before the screening visit.
  4. Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
  5. Seated systolic blood pressure <100mmHg or ≥ 150 mmHg , or diastolic blood pressure of <600mmHg or ≥ 100mmHg at the screening visit
  6. History of alcohol or drug abuse within the 12 months before the screening visit
  7. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
  8. Smoker who smoke more than 20 cigarettes per day
  9. Subjects who take ethical the count or over the count medicine within 10days before the first investigational product administration.
  10. Blood Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
  11. 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.
  12. Subject with known for hypersensitivity reaction to TWYNSTA TAB or dihydropyridine derivatives
  13. Subject with known for hypersensitivity reaction to thiazide diuretics or Sulfonamides
  14. Patients with biliary obstructive disorder
  15. Patients receiving other drugs that affect RAAS such as Angiotensin Receptor Blocker(ARB), ACE inhibitors or aliskiren
  16. Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60mL/min/1.73m2)
  17. Patients with severe hepatic impairment
  18. Patients with severe aortic stenosis
  19. Patients with history of shock
  20. Patients with anuria
  21. Patients with acute or severe renal failure
  22. Patients with hyponatraemia hypokalemia
  23. Patients with Addison's disease
  24. Patients with hypercalcemia of malignancy
  25. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
  26. Test subjects who is not willing or unable to comply with guidelines described in this protocol
  27. A person who is not determined unsuitable to participate in this test by the researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAH tablet
Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet
Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 25 mg combination-drug would be administered orally once
Active Comparator: Telmisartan+Amlodipine besylate+Hydrochlorothiazide
coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide
TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once
Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2016

Primary Completion (Actual)

April 6, 2016

Study Completion (Actual)

April 6, 2016

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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