Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: YHP2205; Drug: YHR2401

Study type: Interventional

Funder types: Industry

Identifiers

NCT06359626

YHP2205-101

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Sequence Group A

Experimental group

Description:

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

Treatment:

Drug: YHR2401

Drug: YHP2205

Sequence Group B

Experimental group

Description:

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

Treatment:

Drug: YHR2401

Drug: YHP2205