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

NCT02739672 | Completed Phase 1

• 1 other identifier: ID-TAH-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUClast

  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

  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)

Study Arms (2)

TAH tablet

EXPERIMENTAL

Telmisartan/Amlodipine besylate/Hydrochlorothiazide tablet

Drug: TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide)

Telmisartan+Amlodipine besylate+Hydrochlorothiazide

ACTIVE COMPARATOR

coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide

Drug: TWYNSTA(Telmisartan+Amlodipine besylate); Drug: Hydrochlorothiazide

Interventions

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

TAH tablet

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

Telmisartan+Amlodipine besylate+Hydrochlorothiazide

Hydrochlorothiazide DRUG

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

Telmisartan+Amlodipine besylate+Hydrochlorothiazide

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Chonbuk National University Hospital

Chonbuk, 561-712, South Korea

Location

MeSH Terms

Interventions

Telmisartan; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 15, 2016
• Study Start: January 2, 2016
• Primary Completion: April 6, 2016
• Study Completion: April 6, 2016
• Last Updated: January 26, 2017

Record last verified: 2016-04

Locations

KR (1)