NCT02608242

PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Detailed description

This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three 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 YH22189 FDC or telmisartan/amlodipine or rosuvastatin 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 three treatment periods will be separated by a washout period.

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	YH22189
DRUG	Twynsta 80/10mg
DRUG	Crestor 20mg

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-11-18
• Last updated: 2017-02-01

Locations

1 site across 1 country: South Korea