Overview

This trial is active, not recruiting.

Condition essential hypertension
Treatments tah tablet (telmisartan/amlodipine besylate/hydrochlorothiazide), twynsta(telmisartan+amlodipine besylate), hydrochlorothiazide
Phase phase 1
Sponsor IlDong Pharmaceutical Co Ltd
Start date February 2016
End date July 2016
Trial size 40 participants
Trial identifier NCT02739672, ID-TAH-102

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet
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)
coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide
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
hydrochlorothiazide
Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once

Primary Outcomes

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)
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)

Eligibility Criteria

Male participants from 19 years up to 55 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by IlDong Pharmaceutical Co Ltd.