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
Overview
- Phase
- Phase 1
- Intervention
- YHP1906
- Conditions
- Healthy Volunteers
- Sponsor
- Yuhan Corporation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Area under the plasma drug concentration-time curve [AUCt]
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Detailed Description
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Group 1
15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
Intervention: YHP1906
Group 1
15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
Intervention: YHR1902
Group 2
15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8
Intervention: YHP1906
Group 2
15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8
Intervention: YHR1902
Outcomes
Primary Outcomes
Area under the plasma drug concentration-time curve [AUCt]
Time Frame: 0-36 hours
Area under the plasma drug concentration-time curve \[AUCt\] of Apixaban
Maximum plasma concentration [Cmax]
Time Frame: 0-36 hours
Maximum plasma concentration \[Cmax\] of Apixaban
Secondary Outcomes
- 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)