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

NCT ID: NCT02739672

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-02
• Study Completion Date: 2016-04-06

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAH tablet

Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet

Group Type: EXPERIMENTAL

TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide)

Intervention Type: DRUG

Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 25 mg combination-drug would be administered orally once

Telmisartan+Amlodipine besylate+Hydrochlorothiazide

coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide

Group Type: ACTIVE_COMPARATOR

TWYNSTA(Telmisartan+Amlodipine besylate)

Intervention Type: DRUG

TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once

Hydrochlorothiazide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Hydrochlorothiazide

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonbuk National University Hospital

Chonbuk, , South Korea

Countries

South Korea

Other Identifiers

ID-TAH-102

Identifier Type: -

Identifier Source: org_study_id