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
1 other identifier
interventional
180
1 country
1
Brief Summary
This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hypertension
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 25, 2015
September 1, 2015
3 months
June 30, 2015
September 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Bioequivalence study is based on Cmax and AUC parameters
1 month
Study Arms (4)
Group 1 - Period 1
ACTIVE COMPARATORTelmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Group 2 - Period 1
EXPERIMENTALYH22162 FDC tablet of Yuhan Corporation
Group 1 - Period 2
EXPERIMENTALYH22162 FDC tablet of Yuhan Corporation
Group 2 - Period 2
ACTIVE COMPARATORTelmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonbuk National University Hospital
Jeonju, 561-712, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingul Kim, MD, Ph.D
Chonbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 14, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 25, 2015
Record last verified: 2015-09