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Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

Y

Yuhan

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: YHP2305
Drug: YHR2404

Study type

Interventional

Funder types

Industry

Identifiers

NCT06613139
YHP2305-101

Details and patient eligibility

About

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

Full 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.

Enrollment

34 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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Group A(RT)
Experimental group
Description:
17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8
Treatment:
Drug: YHR2404
Drug: YHP2305
Group B(TR)
Experimental group
Description:
17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8
Treatment:
Drug: YHR2404
Drug: YHP2305

Trial contacts and locations

1

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Central trial contact

Jinhyun Choi

Data sourced from clinicaltrials.gov

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