Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2024-07-06

Brief Summary

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A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

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Detailed Description

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60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8

Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

two-way crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence Group A

30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8

Group Type EXPERIMENTAL

YHP2205

Intervention Type DRUG

Test drug: YHP2205

YHR2401

Intervention Type DRUG

comparator: YHR2401

Sequence Group B

30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8

Group Type EXPERIMENTAL

YHP2205

Intervention Type DRUG

Test drug: YHP2205

YHR2401

Intervention Type DRUG

comparator: YHR2401

Interventions

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YHP2205

Test drug: YHP2205

Intervention Type DRUG

YHR2401

comparator: YHR2401

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Those who are 19 years old or older at the screening visit
* Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
* Those who express their voluntary consent to participate in the trial by signing a written consent

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.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes