Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults

This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51.

This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.

Inclusion criteria

• Healthy adults over the age of 19 years at the time of screening
• Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9 kg/m2 and total body weight ≥ 50 kg

• BMI = Weight(kg)/ Height(m)2
• Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
• Individuals who agreed proper contraception during the study
• Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation

Exclusion criteria

• Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
• Individuals with an active chronic or acute disease within 1 month.
• Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
• Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
• Individuals with the following medical histories at screening test:

• T1DM or diabetic ketoacidosis
• Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
• Renal disorder or pancreatitis etc.
• A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first
• Individuals who cannot eat standard meal in institution
• Women who are pregnant or may be pregnant
• Individuals who were deemed to be inappropriate to participate in the study by the investigator