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

NCT05040880 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-02-16

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05040880 on ClinicalTrials.gov