Bioequivalence Study Between YHP2508C and YHR2603 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YHP2508C, YHR2603.
- Who it may be relevant to
- Registry conditions: Healthy Subjects. Basic parameters: 19 years — 54 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508C and YHR2603 in Healthy Subjects
Overview
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects
Detailed description
44 healthy subjects will be randomized to one of 2 groups in the same ratio.
Subjects in group 1 will be administered "YHR2603" and "YHP2508C" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508C" and " YHR2603" by crossover design on periods 1 to 4.
Interventions
- Drug YHP2508C
Test drug - Drug YHR2603
Comparator drug
Primary outcome measures
- Area under the plasma drug concentration-time curve [AUCt] [Time frame: 0-72 hours]
- Maximum plasma concentration [Cmax] [Time frame: 0-72 hours]
Secondary outcome measures (4)
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] [Time frame: 0-72 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: 0-72 hours]
- Time of peak concentration [Tmax] [Time frame: 0-72 hours]
- Terminal phase of half-life [t1/2] [Time frame: 0-72 hours]
Eligibility criteria
Inclusion criteria
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
Exclusion criteria
- Those who have participated in a bioequivalence study or other clinical trials and have been administered investigational products within 6 months prior to the first administration.
- Those who are judged ineligible to participate in the trial by the principal investigator.
- Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07584304 · YHP2508-101