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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04316065

Enrollment

Registered

2020-03-20

Start date

2020-04-11

Completion date

2020-04-24

Last updated

2020-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics, Bioequivalence

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

Interventions

DRUGYHP1906

YHP1906 Tab. 5 mg

DRUGYHR1902

Comparator. YHR1902 Tab. 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2 2. Acceptable medical history, physical examination and laboratory tests during screening 3. 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

1. History of clinically significant disease 2. Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing 3. Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin \> 1.5 times of normal upper limit 4. Volunteers considered not eligible for the clinical trial by the investigator 5. Administration of other investigational products within 6 months prior to the first dosing

Design outcomes

Primary

Measure	Time frame	Description
Area under the plasma drug concentration-time curve [AUCt]	0-36 hours	Area under the plasma drug concentration-time curve \[AUCt\] of Apixaban
Maximum plasma concentration [Cmax]	0-36 hours	Maximum plasma concentration \[Cmax\] of Apixaban

Secondary

Measure	Time frame	Description
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 from time 0 to infinity \[AUCinf\] of Apixaban
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	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
Time of peak concentration [Tmax]	0-36 hours	Time of peak concentration \[Tmax\] of Apixaban
Terminal phase of half-life [t1/2]	0-36 hours	Terminal phase of half-life \[t1/2\] of Apixaban

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026