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Completed

NCT Number: NCT02739672

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

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Chonbuk, 561-712, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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

Hydrochlorothiazide

Drug

Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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