NCT05040880

A Bioequivalence Study Between Telmione Plus 80/12.5mg and Micardis Plus 80/12.5 mg in Healthy Adult Volunteers

A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of TELMIONE PLUS TAB. 80/12.5mg and MICARDIS PLUS TAB. 80/12.5mg in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To compare the pharmacokinetics and safety after a single dose administration of Telmione plus® 80/12.5mg and Micardis plus® 80/12.5mg in healthy adult volunteers

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Telmione plus 80/12.5mg	Test drug (Fixed-dose combination drug of telmisartan 80mg and hydrochlorothiazide 12.5mg)
DRUG	Micardis plus 80/12.5mg	Reference drug (Fixed-dose combination drug of telmisartan 80mg and hydrochlorothiazide 12.5mg)

Timeline

• Start date: 2021-07-08
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2021-09-10
• Last updated: 2022-02-16

Locations

1 site across 1 country: South Korea