Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

NCT03662620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-11-12

No results posted yet for this study

Summary

This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.

Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.

Conditions

Interventions

DRUG

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

White colored oval three-layer tablet

DRUG

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

White and pink colored oval two-layer tablet

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Mingul Kim, MD · Chonbuk National University Hospital

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
2018-10-05
Primary Completion
2018-12-08
Completion
2018-12-22

Countries

  • South Korea

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Entities

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 NCT03662620 on ClinicalTrials.gov