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Completed
NCT07470125
Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers
Conditions: Healthy Subjects
Sex: All
Ages: 19 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 61
Sponsor: Yuhan Corporation
Location: H Plus Yangji Hospital Seoul
Summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers
Eligibility Criteria
Inclusion Criteria:
* Adults aged 19 to 55 years at the time of screening visit.
* Those whose weight is ≥ 50 kg (≥ 45 kg for females) 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.
Source: ClinicalTrials.gov (NCT07470125). StuddyBuddy aggregates publicly available trial information.