Overview

Compare the Pharmacokinetics of TAH(80/10/12.5) Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers

Status:
Completed
Trial end date:
2016-12-27
Target enrollment:
0
Participant gender:
Male
Summary
randomized, open-label, single dose, replicate crossover clinical trial to compare the pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
IlDong Pharmaceutical Co Ltd
Treatments:
Amlodipine
Hydrochlorothiazide
Telmisartan
Telmisartan amlodipine combination
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