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Completed

NCT Number: NCT04316065

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. 5mg in healthy volunteers

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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Metro Hospital

Anyang-si, Gyeonggi-do, 14096, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHP1906

Drug

YHP1906 Tab. 5 mg

YHR1902

Drug

Comparator. YHR1902 Tab. 5 mg

Primary outcomes

  1. 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

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-36 hours

    Maximum plasma concentration [Cmax] of Apixaban

Secondary outcomes

  1. Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

    Time frame: 0-36 hours

    Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Apixaban

  2. Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]

    Time frame: 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

  3. Time of peak concentration [Tmax]

    Time frame: 0-36 hours

    Time of peak concentration [Tmax] of Apixaban

  4. Terminal phase of half-life [t1/2]

    Time frame: 0-36 hours

    Terminal phase of half-life [t1/2] of Apixaban

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Collaborators

  • Metro Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2020
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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