NCT03662620

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

A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64. In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

Conditions

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-05
• Primary completion: 2018-12-08
• Completion: 2018-12-22
• First posted: 2018-09-07
• Last updated: 2024-11-12

Locations

1 site across 1 country: South Korea