Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
1 other identifier
interventional
34
1 country
1
Brief Summary
A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2019
Shorter than P25 for phase_1
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
December 19, 2019
CompletedFirst Submitted
Initial submission to the registry
January 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2020
CompletedJanuary 23, 2020
January 1, 2020
20 days
January 8, 2020
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUCt
AUCt of Varenicline
0-96 hours
Cmax
Cmax of Varenicline
0-96 hours
Secondary Outcomes (3)
AUCinf
0-96 hours
Tmax
0-96 hours
t1/2
0-96 hours
Study Arms (2)
Group1
OTHER16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8
Group2
OTHER16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
You may not qualify if:
- History of clinically significant disease
- Sitting blood pressure meeting the following criteria at screening:
- ≤ systolic blood pressure ≤90 (mmHg)
- ≤ diastolic blood pressure ≤ 60 (mmHg)
- Have AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit or Total bilirubin \> 2.0 mg/dl at the time of screening
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 month prior to the first dosing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuhan Corporationlead
- Chonbuk National University Hospitalcollaborator
Study Sites (1)
Chonbuk national university hospital
Jeonju, Jeollabuk-do, 54907, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingul Kim, PhD
Chonbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2020
First Posted
January 13, 2020
Study Start
December 19, 2019
Primary Completion
January 8, 2020
Study Completion
January 14, 2020
Last Updated
January 23, 2020
Record last verified: 2020-01