NCT02496910

PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

Detailed description

This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions. Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	YH22162
DRUG	Telmisartan/Amlodipine 80/5 mg (FDC)
DRUG	Chlorthalidone 25mg

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-07-14
• Last updated: 2015-09-25

Locations

1 site across 1 country: South Korea