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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

NCT03032315 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-01-26

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5)

Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 12.5 mg combination-drug would be administered orally once

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

DRUG

Hydrochlorothiazide

Dichlozid 1 Tab.(Hydrochlorothiazide 12.5 mg) would be administered orally once

Sponsors & Collaborators

  • IlDong Pharmaceutical Co Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2016-12-27
Completion
2016-12-27

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032315 on ClinicalTrials.gov