Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg

Study Overview
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Brief Summary
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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

Detailed Description
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30 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered comparator and YHP1906 Tab. 5 mg by cross-over design on day 1, 8. Subjects in group 2 will be administered YHP1906 Tab. 5 mg and comparator by cross-over design on day 1, 8

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: YHP1906
* Drug: YHR1902


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8 | Drug: YHP1906<br>* YHP1906 Tab. 5 mg<br>Drug: YHR1902<br>* Comparator. YHR1902 Tab. 5 mg<br>|
| Other: Group 2<br>15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8 | Drug: YHP1906<br>* YHP1906 Tab. 5 mg<br>Drug: YHR1902<br>* Comparator. YHR1902 Tab. 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Apixaban | 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] | Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Apixaban | 0-36 hours | 
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Apixaban | 0-36 hours | 
| Terminal phase of half-life [t1/2] | Terminal phase of half-life [t1/2] of Apixaban | 0-36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Bioequivalence