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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: YHP1906; Drug: YHR1902

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of, 14096
      • Metro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; 15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8	Drug: YHP1906; YHP1906 Tab. 5 mg; Drug: YHR1902; Comparator. YHR1902 Tab. 5 mg
Other: Group 2; 15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8	Drug: YHP1906; YHP1906 Tab. 5 mg; Drug: YHR1902; Comparator. YHR1902 Tab. 5 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time of peak concentration [Tmax]	Time of peak concentration [Tmax] of Apixaban	0-36 hours
Terminal phase of half-life [t1/2]	Terminal phase of half-life [t1/2] of Apixaban	0-36 hours

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Collaborators: Metro Hospital
• Investigators: Principal Investigator: Sungdae Kwon, Metro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2020
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 24, 2020

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioequivalence
• Other Study ID Numbers: YHP1906-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No