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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: YHP1906; Drug: YHR1902

• Registration Number: NCT04316065
• Lead Sponsor: Yuhan Corporation

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

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Study Start: 2020-04-11
• Primary Completion: 2020-04-20
• Study Completion: 2020-04-24
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	YHP1906	15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
Group 2	YHR1902	15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8
Group 1	YHR1902	15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8
Group 2	YHP1906	15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Metro Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of