Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg
A Randomized, Open-label, Single-dose, 2-sequence, 2-period, Crossover Clinical Trial to Investigate the Bioequivalence Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Apr 2020
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
First Submitted
Initial submission to the registry
March 18, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
April 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2020
CompletedMay 26, 2020
May 1, 2020
9 days
March 18, 2020
May 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve \[AUCt\] of Apixaban
0-36 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration \[Cmax\] of Apixaban
0-36 hours
Secondary Outcomes (4)
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
0-36 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
0-36 hours
Time of peak concentration [Tmax]
0-36 hours
Terminal phase of half-life [t1/2]
0-36 hours
Study Arms (2)
Group 1
OTHER15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
Group 2
OTHER15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
- Acceptable medical history, physical examination and laboratory tests 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 detailed explanation of the purpose, contents, and characteristic of the drug
You may not qualify if:
- History of clinically significant disease
- Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
- Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin \> 1.5 times of normal upper limit
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 months prior to the first dosing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuhan Corporationlead
- Metro Hospitalcollaborator
Study Sites (1)
Metro Hospital
Anyang-si, Gyeonggi-do, 14096, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Sungdae Kwon
Metro 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
March 18, 2020
First Posted
March 20, 2020
Study Start
April 11, 2020
Primary Completion
April 20, 2020
Study Completion
April 24, 2020
Last Updated
May 26, 2020
Record last verified: 2020-05