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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316065
• Other study ID #: YHP1906-101
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2020
• Est. completion date: April 24, 2020

Study information

• Verified date: May 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 24, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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(?GT) 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• YHP1906
YHP1906 Tab. 5 mg
• YHR1902
Comparator. YHR1902 Tab. 5 mg

Locations

Country	Name	City	State
Korea, Republic of	Metro Hospital	Anyang-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Yuhan Corporation	Metro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma drug concentration-time curve [AUCt]	Area under the plasma drug concentration-time curve [AUCt] of Apixaban	0-36 hours
Primary	Maximum plasma concentration [Cmax]	Maximum plasma concentration [Cmax] of Apixaban	0-36 hours
Secondary	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
Secondary	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
Secondary	Time of peak concentration [Tmax]	Time of peak concentration [Tmax] of Apixaban	0-36 hours
Secondary	Terminal phase of half-life [t1/2]	Terminal phase of half-life [t1/2] of Apixaban	0-36 hours