Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

November 14, 2024 updated by: Yuhan Corporation

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2305 and YHR2404 in Healthy Subjects

An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.

Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Those who are 19 years old or older at the screening visit
  • Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
  • Those who express their voluntary consent to participate in the trial by signing a written consent
  • Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

Exclusion Criteria:

  • Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
  • Others who are judged ineligible to participate in the trial by the principal investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A(RT)
17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8
Drug: YHP2305
Test drug: YHP2305 Comparator: YHR2404
Drug: YHR2404
Test drug: YHP2305 comparator: YHR2404
Experimental: Group B(TR)
17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8
Drug: YHP2305
Test drug: YHP2305 Comparator: YHR2404
Drug: YHR2404
Test drug: YHP2305 comparator: YHR2404

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time Frame: 0-36 hours
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]
Time Frame: 0-36 hours
0-36 hours
Time of peak concentration [Tmax]
Time Frame: 0-36 hours
0-36 hours
Terminal phase of half-life [t1/2]
Time Frame: 0-36 hours
0-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Taegon Hong, Locations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YHP2305-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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