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

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ClinicalTrials.gov Identifier: NCT02739672
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide) Drug: TWYNSTA(Telmisartan+Amlodipine besylate) Drug: Hydrochlorothiazide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2016
Actual Primary Completion Date : April 6, 2016
Actual Study Completion Date : April 6, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAH tablet
Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet
Drug: 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

Active Comparator: Telmisartan+Amlodipine besylate+Hydrochlorothiazide
coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide
Drug: 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: Hydrochlorothiazide
Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739672


Locations
Korea, Republic of
Chonbuk National University Hospital
Chonbuk, Korea, Republic of, 561-712
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd

Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02739672     History of Changes
Other Study ID Numbers: ID-TAH-102
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Telmisartan
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists