NCT02739672

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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
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 25.0 mg) would be administered orally once

Timeline

• Start date: 2016-01-02
• Primary completion: 2016-04-06
• Completion: 2016-04-06
• First posted: 2016-04-15
• Last updated: 2017-01-26

Locations

1 site across 1 country: South Korea