This trial has been terminated.

Conditions hypertension, hyperlipidemia
Treatments yh22189, twynsta 80/10mg, crestor 20mg
Phase phase 1
Sponsor Yuhan Corporation
Start date November 2015
End date December 2016
Trial size 123 participants
Trial identifier NCT02608242, YH22189-102


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
YH22189 FDC tablet of Yuhan Corporation
(Active Comparator)
Telmisartan/Amlodipine 80/10mg (FDC)
twynsta 80/10mg Telmisartan/Amlodipine 80/10mg(FDC)
(Active Comparator)
Rosuvastatin 20mg
crestor 20mg Rosuvastatin 20mg

Primary Outcomes

Telmisartan Cmax
time frame: 0 - 72 hrs
Telmisartan AUClast
time frame: 0 - 72 hrs
Amlodipine Cmax
time frame: 0 - 168 hrs
Amlodipine AUClast
time frame: 0 - 168 hrs
Rosuvastatin Cmax
time frame: 0 - 48 hrs
Rosuvastatin AUClast
time frame: 0 - 48 hrs

Eligibility Criteria

Male participants from 19 years up to 50 years old.

Inclusion Criteria: - Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2 - Who has not suffered from clinically significant disease - Provision of signed written informed consent Exclusion Criteria: - History of and clinically significant disease - A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs - Administration of other investigational products within 3 months prior to the first dosing - Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs - Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Yuhan Corporation.