Overview
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers
Description
60 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" and "comparator" by crossover design on period 1, 2.
Eligibility
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.
